Operation Pangea V: A Global Attack on Online Prescription Drug Pharmacies

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The U.S. Food and Drug Administration (FDA), in partnership with multiple international regulatory and law enforcement agencies, targeted over 4,100 internet pharmacies that allegedly sell potentially dangerous, unapproved drugs to consumers. On October 4, 2012, the FDA announced the details of Operation Pangea V, a global effort to combat the online sale and distribution of potentially counterfeit and illegal medical products. (For the full text of the FDAs press release, please click here.) In executing Operation Pangea V, the FDA collaborated with INTERPOL, the World Customs Organization, Permanent Forum of International Pharmaceutical Crime, Heads of Medicines Agencies Working Group of Enforcement Officers, the Medicines and Healthcare products Regulatory Agency of the United Kingdom, the Irish Medicines Board, the London Metropolitan Police, the U.S. Department of Homeland Security, the Center for Safe Internet Pharmacies, and the national health and law enforcement agencies from 100 other participating countries. The cooperative investigations conducted by these law enforcement, customs, and regulatory authorities resulted in civil and criminal charges, seizure of illegal produces, and removal of websites.

According to the FDA, the goal of Operation Pangea V, which took place between September 25 and October 2, 2012, was two-fold: first, to identify producers and distributors of illegal pharmaceutical products and medical devices and, second, to remove these products from the supply chain. In its press release, the FDA stated that the majority of medicines at issue pose potential health concerns for consumers because “they contain active ingredients that are approved by FDA for use only under the supervision of a licensed health care practitioner or active ingredients that were previously withdrawn from U.S. market due to safety issues.” Some of the medicines identified through Operation Pangea V were Domperidone, Isotretinoin, Tamiflu, and Viagra.

During Operation Pangea V, regulators and customs authorities across the globe inspected over 133,000 packages and confiscated over 3.75 million illicit and counterfeit pills. In total, approximately $10.5 million worth of pharmaceuticals were seized worldwide and over 18,000 pharmacy websites were ordered to shut down its operations. (To read INTERPOLs brief summary of Operation Pangea V, click here.) The FDA referred to the online sale of illegal, unapproved, counterfeit, or potentially adulterated or substandard drugs as an “inherently international crime problem.” To that end, INTERPOL estimates that roughly 80 individuals are currently under investigation or under arrest for criminal offenses, including operating a clandestine laboratory producing counterfeit medicines, membership in a criminal group selling illicit medicine online, and operating websites selling illicit medicines.

Pursuant to its enforcement authority in the United States, the FDA issued a Warning Letter to Canadadrugs, which listed over 4,100 identified websites that purportedly sell illegal or counterfeit drugs or medical devices to American consumers. The operators of each of these 4,100 websites received a copy of the FDAs Warning Letter to Canadadrugs, which explained that these online pharmacy websites “offer unapproved and misbranded new drugs for sale” and requested each website to “immediately cease marketing violative drug products to United States consumers.” (To read the FDAs Warning Letter to Canadadrugs, please click here.) Furthermore, the FDA sent notices to Registries, Internet Service Providers (ISPs), and domain Name Registrars (NDRs) informing them of the websites allegedly violative practices.

The FDA has stated that it will continue to work with international groups to investigate websites that sell potentially unapproved, counterfeit, or adulterated drugs and medical devices. Within the last week, alone, the FDA launched BeSafeRx”Know Your Online Pharmacy, a national campaign to provide consumers with information about the risks of purchasing prescription drugs online.

Fuerst Ittleman David & Joseph, PL will continue to monitor the regulation of online pharmaceutical drug companies. The attorneys in the Food, Drug, and Life Sciences practice group are well-versed in the complex regulatory framework for prescription drugs and medical devices. For more information, please email us at contact@fidjlaw.com or call us at (305) 350-5690.

Medifast Agrees to Settle Advertising Dispute with FTC

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On September 10, 2012, the Federal Trade Commission (“FTC“) announced that Jason Pharmaceuticals, Inc. (“Jason”), a subsidiary of Medifast, Inc. and the makers of Medifast weight loss meal replacement products, agreed to pay $3.7 million to settle charges for allegedly violating a 1992 Consent Decree regarding weight loss claims. This enforcement action is part of the FTCs ongoing effort to make sure that companies comply with FTC consent decrees, and the Commissions crackdown on what it deems to be deceptive and misleading health claims.

According to its Complaint, the FTC alleges that since at least November 2009, Jason violated the FTCs 1992 Consent Decree by making unsubstantiated weight loss claims in advertisements in violation of Sections 5(a) and 12 of the FTC Act, 15 U.S.C. §§ 45(a) and 52. The Complaint also alleges that consumer testimonials in Jasons advertisements conveyed unsubstantiated claims that Medifast products resulted in weight loss of 2 to 5 pounds per week.

The 1992 Consent Decree specifies that Jason must possess “competent and reliable scientific evidence” in order to substantiate heath claims. “Competent and reliable scientific evidence” is defined as “tests, analyses, research, studies, surveys or other evidence conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the relevant profession or science to yield accurate and reliable results.”  However, the newly entered 2012 Consent Decree redefines “competent and reliable scientific evidence” as “one [a]dequate and well-controlled human clinical study” of a “low calorie meal replacement program . . . designed to lower the users total caloric intake” that follows “acceptable designs and protocols” or a protocol “satisfying all of the criteria.”  The criteria require 16-week clinical studies for weight loss claims, and 52-week clinical studies to support any claims related to weight maintenance.

As we have previously reported (here, here, and here), over the past several years the FTC has attempted to employ and enforce a heightened level of substantiation for health related claims through consent decrees. In litigation with companies such as Garden of Life, The Dannon Company, Nestle HealthCare, Iovate Health Sciences and POM Wonderful, the FTC has sought to enforce the definition of “competent and reliable scientific evidence” to require “two adequate and well-controlled human clinical studies for all absolute or comparative claims” and FDA approval for all “disease treatment and cure claims.”

Conversely, the new requirements for substantiation contained in the Jason consent decree mandate one, not two, adequate and well-controlled human clinical studies. This change may be due to the recent trend of courts disagreeing with the FTCs attempts to redefine and enforce a heightened level of substantiation requiring two adequate and well-controlled human clinical studies for health related claims.  As we previously reported, the Garden of Life decision is one example. In FTC v. Garden of Life, the FTC sought to modify a previous consent decree by changing the definition of “competent and reliable scientific evidence” to require “two adequate and well-controlled human clinical studies for all absolute or comparative claims” and FDA approval for disease claims. In rejecting the FTCs position, the Court stated that competent and reliable evidence does not mean “uncontroverted proof.”

For more information on FTC regulations and substantiation requirements, or on how to ensure that your business maintains regulatory compliance at both the state and federal levels, please contact us at contact@fidjlaw.com.

FDA Warning Letters to Sprout Growers Highlight Complicated Legal Issues Associated with Warning Letters and Guidance Documents

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Since 1996, there have been at least 30 reported outbreaks of foodborne illness associated with different types of raw and lightly cooked sprouts caused mostly by Salmonella and E. coli. In 1999, in response to numerous outbreaks and the potential for microbial contaminations, the U.S. Food and Drug Administration (“FDA“) issued two guidance documents,  “Reducing Microbial Food Safety Hazards for Sprouted Seeds” and “Sampling and Microbial Testing of Spent Irrigation Water During Sprout Production,” to assist all parties involved in the production of sprouts to reduce the risk of sprouts spreading foodborne illnesses.

For several years following the issuance of the guidance documents, the FDA reported that foodborne illnesses associated with sprouts appeared to diminish. However, in light of continuing outbreaks, the FDA strongly encouraged firms in the industry to review their operations to reduce microbial food safety hazards for sprouted seeds in accordance with the guidance documents.

Since 1999, the FDA has issued over 80 Warning Letters to firms involved in the production of sprouts. The majority of the Warning Letters state that the sprouts are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 342(a)(4)] because they have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. Please see our previous reports here and here, discussing whether, and if so how, the recipients of these Warning Letters may respond or challenge the Warning Letters in court in light of the United States Supreme Courts recent ruling in Sackett v. EPA.

In addition to the alleged violations, the Warning Letters state that the “proper handling and controls for sprout manufacturing can be found in [the 1999 guidance documents].” Therefore, the guidance documents are closely examined by industry because they provide important insight as to how FDA will act in terms of enforcement. However, FDA guidance documents describe the Agencys current thinking on a regulatory issue, and do not have the force or effect of law.

Because the FDA continues to heavily rely on the voluntary guidelines for enforcement action, the International Sprout Growers Association (“ISGA“), on behalf of the sprout industry, has urged the FDA to update the outdated guidance documents. The ISGA stated that there are numerous new methods for sprout sanitation that are not outlined in the guidance documents. For example, in the E. coli strain found in sprouts at Jimmy Johns restaurants earlier this year would not have been identified by microbiological tests currently recommended under the guidance. Please see our previous report discussing E. coli testing for more information.

Pursuant to Section 105 of the Food Safety and Modernization Act to provide standards for produce safety, on February 28, 2012, the FDA announced the creation of the Sprouts Safety Alliance (“SSA”) in cooperation with the Illinois Institute of Technologys Institute for Food Safety and Health. The SSA is supposed to help sprout producers in identifying and implementing best practices in the safe production of sprouts. The FDA was expected to issue a proposed rule during early 2012 that would establish science-based standards for the production and harvesting of sprouts and other certain produce. However, the FDA has yet to announce the proposed rule as required under Section 105.

For more information, you can contact an attorney by calling us at 305.350.5690 or by emailing us at contact@fidjlaw.com.

FDA Releases CPG for Labeling and Marketing of Therapeutic Animal Foods

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On September 10, 2012, the U.S. Food and Drug Administration (FDA) released a draft compliance policy guide (“CPG”) entitled “Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat or Prevent Disease in Dogs and Cats.”  Therapeutic animal food products are products that, based on the product’s labeling and indications for use, meet the statutory definition of an animal drug under the Federal Food, Drug, and Cosmetic Act (“FDCA”). Pursuant to 21 U.S.C. 321(g)(1)(B), a product that is labeled as intended to diagnose, cure, mitigate, treat, or prevent diseases is a drug. Further, a product that is labeled as intended to provide nutrients in support of an animal’s daily nutrient needs also satisfies the definition of a drug under 21 U.S.C. 321(f). This proposed CPG outlines how the FDA intends to enforce its regulatory authority over the labeling and marketing practices of manufacturers of animal food products that meet these definitions.

Animal food products that purport to diagnose, cure, mitigate, treat, or prevent disease have been available on the U.S. market for over fifty years, but were generally only sold through, and used under the direction of,  licensed veterinarians. The FDA, however, has noticed a recent rise in the sale of therapeutic animal food products directly from manufacturers to consumers. This uptick in marketing and sales toward consumers sparked FDA concern about whether product labeling adequately informs consumers about the effectiveness and safety of products for pet consumption. As a result, the FDA has released this CPG to address continued concerns over the sale and use of unapproved therapeutic animal foods that are not used under the direction of veterinarians.

In this CPG, the FDA takes a stricter stance on how foods that bear health claims should be regulated. Specifically, the FDA takes the position that in order to market these therapeutic animal food products in compliance with federal regulations, manufacturers must obtain animal drug approval from the FDA. This process would require FDA approval indicating that the product is safe for use, only includes food additives that are generally recognized as safe (“GRAS”), and in compliance with requirements for facility registration, listing, and current good manufacturing practices.

According to this CPG, the FDA does not generally intend to recommend or initiate regulatory actions against dog and cat food products that are labeled as drugs when all the following factors are present:

  1. The product is made available to the public only through licensed veterinarians or through retail or internet sales to individuals purchasing the product under the directions of a veterinarian.
  2. The product is not marketed as an alternative to approved new animal drugs.
  3. The manufacturer is registered under section 415 of the FDCA.
  4. The product’s labeling complies with all food labeling requirements for such products.
  5. The product does not include indications for a disease claim (e.g., obesity, renal failure) on the label.
  6. Distribution of labeling and promotional materials with any disease claims for the product is limited to that it is provided only to veterinary professionals.
  7. Electronic resources for the dissemination of labeling information and promotional materials are secured so that they are available only to veterinary professionals.
  8. The product contains only ingredients that are GRAS ingredients, approved food additives, or feed ingredients defined in the 2012 Official Publication of the Association of American Feed Control Officials.
  9. The label and labeling of the product is not false and misleading in other respects.

The release of this CPG puts manufacturers of animal food products on notice that the FDA will closely scrutinize product labeling, particularly any claims that give the impression that a product purports to diagnose, cure, treat, or prevent diseases in animals. The FDA, however, will continue to take into consideration other factors in determining whether to take regulatory enforcement action. Specifically, the FDA has narrowed its enforcement attention to prioritize products that:

  1. Are marketed as alternatives to approved new animal drugs
  2. Contain unapproved food additives, unless the use of that unapproved food additive conforms to uses as listed in the 2012 Official Publication of the Association of American Feed Control Officials
  3. Include words or vignettes on the label of the product(s) that explicitly or implicitly indicate diseases for which the product is to be used.
  4. Are made directly available to the public circumventing the role of a licensed veterinarian for provision of directions for use, supervision of treatment and evaluation of the treatment outcome.

The FDA’s decision to develop and release a CPG on the regulation of therapeutic animal food products is an interesting one. Historically, the FDA has regulated pet foods similarly to human foods. In this CPG, the FDA’s description of therapeutic animal foods sounds rather similar to the language the FDA uses to describe human medical foods under section 21 U.S.C. 360ee(b)(3). The FDA defines a medical food as “a food which is formulated to be consumed under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” In the regulations for medical foods, the FDA species further criteria for meeting the statutory definition of a medical food. The FDA has not outlined similar criteria for animal foods. Even though there are distinct similarities in the FDA’s descriptions of therapeutic pet foods and human medical foods, the FDA has yet to specifically clarify what constitutes a therapeutic pet food product, how it interprets the meaning of use “under the direction of licensed veterinarians,” or whether the sale of these products is restricted to licensed veterinarians.

Despite the lack of clarity regarding the definition of a therapeutic drug product, manufacturers should not take this CPG lightly. The information proposed in this CPG suggests that the FDA intends to strictly enforce animal drug approval requirements for these animal food products and also plans to considerably tighten its oversight on pet food labeling claims. Because the use of health claims on product labeling would require manufacturers to undergo the drug approval process, manufacturers should take extra caution when developing claims about a product’s safety and efficacy in affecting the body or treating health conditions.

Overall, this proposal could have a significant impact on the cost of bringing therapeutic animal food products to market. The heightened threat of enforcement action could result in significant costs associated with filing applications for new drug approval, testing, re-formulation, and/or re-labeling. Moreover, the animal drug approval pathway would likely extend the timeline required for a product to become compliant with applicable regulations and eligible for distribution and sale.

The FDA is currently seeking public comment on this proposed draft compliance policy guide (Docket No. FDA-2012-D-0755). To ensure that comments are considered before the FDA begins work on the final draft, all comments should be submitted prior to November 9, 2012. Fuerst Ittleman David & Joseph will continue to monitor the FDA’s enforcement of this Compliance Policy Guide for therapeutic pet foods. For more information, please contact us at contact@fidjlaw.com

Class Action Lawsuits Allege Deceptive “Natural” Labeling Claims

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As we previously reported here and here, there has been a noticeable increase in the number of lawsuits filed by consumers aiming to challenge “natural” advertising and labeling claims for dietary supplements and food products over the past year. Most recently, on July 26, 2012, a class action lawsuit was filed in the U.S. District Court for the Northern District of California alleging that General Mills, Inc. (“GM”) deceived consumers by marketing its Nature Valley granola bars as natural “when they are not wholly natural.” The complaint alleges GM deceptively uses the term “natural” to describe products containing ingredients that have been fundamentally altered from their natural state.

GM is the maker of Nature Valley food products including granola bars and other snack food items. According to the complaint, GM’s advertising and labeling Nature Valley products as “natural” violates several California consumer protection laws, including the California Legal Remedies Act, the Unfair Competition Law, and the False Advertising Law, because the products contain non-natural, highly processed ingredients such as high fructose corn syrup (“HFCS”), high maltose corn syrup (“HMCS”), maltodextrin, and rice maltodextrin.

Detailed in our previous report, many consumers feel they are being deceived by “natural” marketing claims and have urged the U.S. Food and Drug Administration (“FDA”) to adopt a formal definition for the term “natural.” In 1991, the FDA solicited comments on a potential rule regarding the definition. However, the FDA ultimately declined to adopt a formal definition. Currently, the FDA’s policy states that it considers “natural” to mean “merely that nothing artificial or synthetic (including colors regardless of source) is included, or has been added to, the product that would not normally be there.” 58 F.R. 2302. The informal policy regarding the use of the term “natural” does not carry the force of law. However, the FDA has sent Warning Letters to companies whose products claim to be “natural” yet contain ingredients the Agency regards to be synthetic which caused the product to be deemed to be misbranded pursuant to 21 U.S.C. 343(a)(1).

The uncertainty over the meaning of the term “natural” has brought a wave of recent class action lawsuits. Other products that have also faced consumer class action lawsuits for the use of “natural” claims on advertising and labeling include: ConAgra‘s Wesson Oils, Skinnygirl Margaritas, Kellogg’s Kashi, Tropicana’s not-from-concentrate orange juice, Frito Lay’s Tostitos and SunChips, Snapple beverages, and Ben & Jerry’s ice cream.

The plaintiffs’ attorneys in these cases argue that the “all natural” claim at issue is false and misleading because the product contains unnaturally processed, synthetic substances, or, in the case of Kashi, that the cereal contains genetically modified ingredients. While some products may technically be in compliance with FDA’s policy statement, they are not insulated against private actions because there is a lack of formal FDA or other government definition for “natural” claims. See, e.g., Holk v. Snapple Beverage Corp., 575 F.3d 329 (3rd. Cir. 2009). Without an FDA or other government definition, the plaintiffs’ attorneys can bring these suits and the food manufacturers must prove the claims are not false or misleading. Id. A formal FDA definition of “natural” could set a definitive standard for “natural” and eliminate these lawsuits. Id. For more information regarding what food manufacturers should know about “natural” claims, see please our previous report here.

A formal FDA definition of natural would not only benefit food companies, but it would also provide consumers with a clearer understanding and less confusion. For more information about the regulation of food advertising and labeling claims, please contact us at contact@fidjlaw.com or (305) 350-5690.

Federal Appeals Court Affirms Collateral Consequences of Park Doctrine

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On July 27, 2012, the United States Court of Appeals for the D.C. Circuit in Freidman v. Sebelius upheld the U.S. Department of Health and Human Services (“HHS“) determination to exclude three former Purdue Pharma executives from participating in federal healthcare programs after they pled guilty to misdemeanor misbranding violations under the Federal Food, Drug, and Cosmetic Act (“FDCA”) based on the Park Doctrine. The Freidman case is an example of the potential collateral consequences of Park Doctrine prosecutions.

The Park Doctrine, also known as the “Responsible Corporate Officer Doctrine” (“RCO”), allows corporate officials to be convicted of misdemeanors based entirely on his or her position and responsibility in a corporation. Notably, the Governments burden to support a misdemeanor conviction under Park is relatively low. The Government must only show that the violation occurred and that the alleged person to be the responsible corporate official occupied a position of responsibility where the official could have prevented or corrected the violation. There is no requirement that a person had any criminal intent or acted personally in any wrongdoing, or for that matter, was even aware of a violation. We have previously blogged about the recent use of the Park Doctrine by the U.S. Food and Drug Administration (“FDA“), here and here.

Background

As we previously reported, in 2007, Purdue Pharma L.P. and Purdue Frederick Company, Inc. (hereinafter “Purdue”) pled guilty to one felony count of misbranding in violation of 21 U.S.C. § 331(a) for knowingly and intentionally marketing OxyContin, a schedule II controlled substance, as less addictive, and less subject to abuse and diversion, and less likely to cause tolerance and withdrawal than other pain medications. Additionally, three Purdue executives pled guilty to one count of misdemeanor misbranding in violation of 21 U.S.C. § 331(a) and for their admitted failure to prevent Purdues fraudulent marketing of OxyContin under the Park Doctrine. At sentencing, the three executives were sentenced to probation and disgorged millions of dollars of income.

However, soon after the executives entered their guilty pleas, HHS excluded them from any participation in federal health care programs for 12 years because their convictions were based on fraud and the unlawful manufacture of a controlled substance. As a consequence of this exclusion, the corporate officers will be unable to engage any in business which participates in federal health care programs such as Medicare and Medicaid. HHSs decision was upheld by the U.S. District Court for the District of Columbia.

Appeals Court Decision

On appeal to the United States District Court of Appeals for the D.C. Circuit, the executives argued that (1) their misdemeanor misbranding convictions did not rise to the level of "relating to fraud" as to warrant the penalty of exclusion under 42 U.S.C. § 1320a-7(b)(1), and (2) the length of their exclusions was not supported by substantial evidence and thus was arbitrary and capricious.

In its decision, available here, the Court of Appeals held that HHS has the authority to exclude individuals convicted of a misdemeanor if the conduct underlying the conviction is related to fraud, even if the individual is an executive that had no knowledge of the underlying fraudulent conduct based on the Park Doctrine. However, the Court of Appeals also found that the 12 year exclusion of the Purdue executives was arbitrary and capricious because HHS failed to justify the unprecedented length of the exclusion as required by the Administrative Procedure Act. The Appeals Court therefore remanded the case to the District Court with instructions to remand the matter on to HHS for further consideration of the length of the exclusions.

Significantly, the exclusions in Friedman, even if reduced, constitute a severe penalty for executives facing a misdemeanor prosecution under the Park Doctrine. As we previously reported, the FDA has expressly stated that it will seek to increase the amount of Park Doctrine criminal prosecutions of corporate executives whose companies commit FDCA violations.

The FDA and white collar criminal defense lawyers at Fuerst Ittleman are experienced in handling even the most complex cases where clients are facing allegations of criminal actions. Fuerst Ittleman attorneys have represented clients in a variety of FDA-related criminal investigations and prosecutions including violations of the FDCA under 21 U.S.C. §§ 331 and 333 as well as prosecutions of corporate officials under the Park Doctrine. For more information regarding Fuerst Ittlemans white collar criminal defense practice, contact an attorney today at contact@fidjlaw.com

FDA Clears Ingestible Medical Device through De Novo Review Process

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On May 1, 2012, the U.S. Food and Drug Administration (“FDA”) cleared the Proteus Digital Health, Inc. (“Proteus”) ingestible sensor for marketing as a Class II medical device through the de novo review process. The ingestible sensor is part of digital health feedback system that will relay information to a patient’s healthcare professional from a microchip embedded in pills to monitor a patient’s response to treatment.

The Proteus ingestible sensor can be integrated into medications such as inert pills or other pharmaceutical products. Once the digested sensor reaches the stomach fluid, it communicates a unique signal to a patch worn on the skin that marks the precise time the medication was taken. The patch also collects physiologic and behavioral information, including heart rate, body position and activity. The patch then relays the information to the patient’s healthcare professional through a mobile phone application. As a result, the ingestible sensor allows healthcare professionals to ensure that patients are taking medications as prescribed while receiving feedback on patients’ physical response to treatment.

Currently, the FDA has only cleared the ingestible sensor based on studies establishing its safety and effectiveness when implanted into placebo pills. However, Proteus hopes to have the device cleared for use with drugs in the near future.

Notably, the ingestible sensor device was cleared for marketing by the FDA through de novo review because it is the first device to monitor medication adherence. The de novo review process is available for novel low- and moderate-risk devices that have been found to be not substantially equivalent (“NSE”) to existing predicate devices as a result of a 510(k) submission. Pursuant to Section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), the submitter of a 510(k) may, within 30 days of receipt of an NSE determination for that 510(k), submit a de novo petition requesting the FDA to make a risk-based classification determination for the device under Section 513(a)(1) of the FDCA. If the FDA grants the de novo petition, the device is reclassified from Class III into Class I or Class II. Alternatively, if the petition is denied, the device remains in Class III and may not be marketed until approved by the FDA through submission of a Premarket Approval Application (“PMA”). As a result of the ingestible sensor’s clearance and reclassification as a Class II medical device by the FDA through do novo review, industry may now use the ingestible sensor as a predicate device for future 510(k) submissions.

The FDA’s review of medical devices is complex. Fuerst Ittleman has extensive experience successfully navigating medical devices through FDA review. For more information on FDA’s review of medical devices, please contact us at contact@fidjlaw.com.

FDA Targets Gastric Band Surgery Advertisements

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In late 2011, the U.S. Food and Drug Administration (“FDA“) launched an initiative targeting marketers of gastric band surgery following the death of five patients. The FDA is concerned that gastric band advertisements glamorize the surgical procedure without communicating any of the risks. Many of these advertisements feature slender men and women claiming to have lost massive amounts of weight and gained control of their lives solely as a result of undergoing gastric band surgery.

Gastric banding is a surgical procedure intended to reduce the size of the stomach for weight loss by placing a silicone band around the upper portion of the stomach to create a small pouch.  As of todays date, the FDA has approved two gastric banding devices, the Lap-Band by Allergan, Inc. and the Realize Adjustable Gastric Band by Ethicon Endo-Surgery, Inc.

Pursuant to the Federal Food, Drug and Cosmetic Act (“FDCA”), product advertising for certain medical devices, such as gastric bands, must contain relevant warnings and information regarding precautions, side effects, and contraindications. Advertisements that do not contain all of the required information are considered misleading. As a result of misleading advertisements, the medical device will be deemed to be misbranded. 

On December 13, 2011, the FDA issued Warning Letters for misleading gastric band advertisements and misbranded gastric band devices to eight surgical centers and one marketing firm. On June 25, 2012, the FDA issued another Warning Letter to a doctor for Lap-Band advertisements which misbrand the device pursuant to Sections 502(q), 502(r), and 201(n) of the FDCA. The Warning Letters stated that the advertisements failed to reveal material facts, including relevant risk information regarding the use of the gastric band, age and other qualifying requirements for the procedure, and the need for ongoing modification of eating habits, as provided in the approved gastric band device labeling.

FDA Warning Letters notify the recipient and the public that the FDA believes that a particular firm has violated federal law. Thus, given the bad publicity that these letters generate, it is advantageous for firms to correct possible violations even before the FDA issues Warning Letters. The recipients of Warning Letters have 15 days to address the misbranding issues contained in the Warning Letter and to develop specific corrective actions. Failure to do so may put the recipient in jeopardy of facing product seizures or formal legal action by the FDA. Although some courts have previously ruled that Warning Letters are not immediately challengeable in federal court, the United States Supreme Courts recent ruling in Sackett v. EPA (which we discussed here) may have created a sea change in that jurisprudence. We will follow this issue closely, both for our clients and this blog. 

For more information, you can contact an attorney by calling us at 305.350.5690 or by emailing us at contact@fidjlaw.com.

FDA Issues Draft Guidance for Medical Device Pre-Submission Program

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On July 13, 2012, the U.S. Food and Drug Administration (“FDA“) issued a Draft Guidance document entitled “Medical Devices: The Pre-Submission Program and Meetings with FDA Staff” (“the Guidance”). The Guidance outlines the Agencys recommendations and procedures for medical device manufacturers and researchers who want early feedback and advice before submitting product- or research-specific applications. When final, the Guidance will supersede the 1999 guidance entitled “Pre-IDE Program: Issues and Answers – Blue Book Memo D99-1.” 

The Guidance expands on the pre-Investigational Device Exemption (“pre-IDE”) program and will now be referred to as the Pre-Submission (“Pre-Sub”) program. The pre-IDE program allows applicants to obtain feedback on a product during the investigational stage and prior to the formal application process. The Pre-Sub program broadens the pre-IDE program to include Premarket Approval (PMA), Humanitarian Device Exemption (HDE), Premarket Notification (510(k)), and de novo submissions.

The FDA states that the Pre-Sub program will provide more timely regulatory actions and innovative new devices for patients through improved submissions. The Guidance advises applicants how to improve their pre-market submissions by:

  • describing when device developers might benefit from early FDA feedback;
  • describing pre-submissions package content necessary for optimal FDA feedback: and
  • explaining how to best engage FDA in informal meetings to discuss the most efficient path with a new technology or  planned regulatory submission 

The FDA cautions that the Pre-Sub program is not an alternative to traditional approval and clearance processes. Instead, the Pre-Sub program is intended to help industry identify regulatory requirements early in the device development process to facilitate earlier, more transparent, and more predictable interactions with the FDA. The Guidance stresses that the Pre-Sub program is designed to answer specific questions an applicant may have during product development.

The Pre-Sub program is part of the FDAs effort to strengthen its image regarding the safety of medical device products after facing criticism regarding the 510(k) program. Last year, the Institute of Medicine (“IOM”) released a report which assessed the overarching structure of the 510(k) process and its ability to sufficiently monitor and oversee the safety and efficacy of medical devices on the market. Overall, the IOM identified substantial problems with the FDAs 510(k) process and suggested the FDA integrate a premarket and post-market regulatory framework that provides for reasonable assurance of safety and effectiveness throughout the device life cycle. Please see our previous report for more information regarding the IOM report.

The medical device industry has also criticized the FDAs medical device review process. For years industry has complained about slow FDA review. The Pre-Sub program is expected to improve review times due to improved submission quality from applicants. The FDA states that the Pre-Sub program will provide industry with enhanced predictability and transparency during the medical device review process.   

However, the FDA notes that its ability to hold timely meetings is contingent upon its resources, which are often strained. The FDA estimates that it will receive approximately 2,544 pre-submission meeting requests annually. Each meeting request is estimated to involve 137 hours of work per applicant. Thus, the extent of the effect of the Pre-Sub program on review times remains to be seen.

Anyone can submit comments on the Guidance at any time. However, in order to ensure that the FDA considers comments on this Guidance when developing the final guidance, electronic or written comments should be submitted by October 11, 2012. Electronic comments should be submitted here. Written comments should be submitted to the Division of Dockets Management, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

The FDAs review of medical devices is complex. Fuerst Ittleman has extensive experience successfully navigating medical devices through FDA review. For more information on FDAs review of medical devices, please contact us at contact@fidjlaw.com.

POM Wonderful and FTC Appeal Initial Decision

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As we previously reported, in September 27, 2010, the Federal Trade Commission (“FTC“) filed a complaint against POM Wonderful LLC (“POM“) for allegedly making unsubstantiated claims, which were also false or misleading in violation of Sections 5(a) and 12 of the Federal Trade Commission Act (“FTC Act“). In its Complaint, the FTC alleged that POMs claims that its products prevent, reduce the risk of, or treat heart disease, high blood pressure, prostate cancer, and erectile dysfunction (“ED”) were not supported by competent and reliable evidence. Additionally, the Complaint contained a proposed cease and desist order that would require, among other things, U.S. Food and Drug Administration (“FDA“) approval of certain disease claims for POMs products.

On May 17, 2012, an FTC Administrative Law Judge (“ALJ”) held in an Initial Decision that POMs claims that its products could treat, prevent, or reduce the risk of heart disease, prostate cancer, and ED were deceptive because these claims were not supported by sufficient competent and reliable evidence. However, the Decision rejected the FTCs theory that POM was required to have double-blind, randomized placebo-controlled clinical trials (RCTs) to make the claims that the FTC attacked. The Decision clarified that the standard for substantiation is competent and reliable scientific evidence. The ALJ also held that the FTCs proposed requirement that POM be prohibited from making any disease claim in the future unless the claim had been pre-approved by FDA “would constitute unnecessary overreaching.”

Both POM and the FTC appealed the Initial Decision to the FTC Commissioners. POM appealed all portions of the Decision relating to the finding of liability. The FTC appealed the ALJs conclusion arguing that (1) all advertisements challenged in the Complaint violated the FTC Act, (2) the substantiation of disease efficacy claims should require well-designed, well-conducted RCTs, and (3) the ALJ erred in not adopting the proposed remedy to require FDA approval for all future claims that any POM product is effective in the diagnosis, cure, mitigation, treatment or prevention of diseases. The appeal briefs for POM and the FTC can be read here and here respectively.

If the ALJs Initial Decision is upheld, it will establish that the FTC exceeded its authority by requiring RCTs and FDA preapproval to substantiate food and dietary supplement claims. Marketers of food and dietary supplements will therefore be able to continue to promote health benefits that are supported by competent and reliable scientific evidence, without conducting RCTs and obtaining FDA preapproval.

Nevertheless, in the past two years, the FTC has reached numerous settlements in which it has persuaded marketers of food and dietary supplements to conform to a new standard for substantiation requiring RCTs, particularly with respect to weight-loss and disease-fighting claims. Recently published consent orders include those against Nestle USA, Iovate Health Sciences, Inc., and The Dannon Company, Inc., in which the FTC prohibits future claims by the companies unless the claims are supported by two well-controlled RCTs. Please see our previous report for more information regarding these agreements.

In a recent trend, Courts have disagreed with the FTCs attempts to redefine and enforce a heightened level of substantiation for health related claims. As we previously reported, the Garden of Life (“GOL”) decision is one example. In FTC v. Garden of Life, the FTC sought to modify a previous consent decree by changing the definition of “competent and reliable scientific evidence” to require “two adequate and well-controlled human clinical studies for all absolute or comparative claims” and FDA approval for disease claims. In rejecting the FTCs position, the Court stated that competent and reliable evidence does not mean “uncontroverted proof.”

The next step in the process is for the five FTC Commissioners to hear oral argument and make a final decision regarding whether to adopt, in whole or in part, or not at all, the ALJs Initial Decision.  Oral argument before the Commission is scheduled for August 23, 2012. Fuerst Ittleman will continue to monitor the development of the POM case. For more information about food and dietary supplement claims or to have Fuerst Ittleman complete a label and website review of your products, please contact us at (305) 350-5690 or contact@fidjlaw.com.