GlaxoSmithKline Agrees to Pay $3 Billion over Avandia Marketing

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On November 3, 2011, GlaxoSmithKline (GSK) agreed to a settlement with the U.S. Department of Justice (DOJ) for a record-breaking $3 billion. The settlement, which is expected to be finalized in early 2012, involves multiple civil and criminal claims filed against GSK for the alleged off-label marketing of its widely controversial diabetes drug Avandia. In particular, the government alleged that GSK had illegally marketed Avandia for uses that were not approved in the products labeling.

The governments prohibition of “off-label” marketing, or promoting a drug for uses other than those approved by the U.S. Food and Drug Administration (FDA), is a highly-contentious issue. While it is widely accepted that licensed practitioners may prescribe drugs for uses other than those approved by the FDA, drug manufacturers are prohibited from marketing such uses, even where the new uses show no signs of adverse events. However, although the FDA views its prohibition on off-label promotion as well-settled, challenges by drug manufacturers have called the legal grounding of this prohibition into question. Recently, various pharmaceutical manufacturers have brought challenges against the FDA regarding restrictions on off-label promotions, arguing that the prohibition violates the First Amendment. In addition, as previously reported, drug manufacturers petitioned the FDA in July 2011 requesting that the Agency solidify its stance on off-label marketing by promulgating regulations and publishing other guidance in this area.

For more information on FDA regulations and acceptable pharmaceutical marketing practices please contact us at contact@fidjlaw.com.

Senate Bill Seeks to Reinforce Least Burdensome Provisions for Medical Device Review

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On October 13, 2011, Senator Amy Klobuchar introduced a bill before the United States Senate, entitled the “Medical Device Regulatory Improvement Act.” Found here, the bill is aimed at amending the Federal Food, Drug and Cosmetic Act (FDCA) in an effort to increase efficiency in the way medical devices are reviewed by the U.S. Food and Drug Administration (FDA). In particular, the bill seeks to require the FDA to consider alternative ways of determining device safety and effectiveness, by requiring the agency to consider “alternatives to randomized, controlled clinical trials, such as the use of surrogate endpoints.” Additionally, the bill states that the FDA “shall not request information unrelated or irrelevant to a demonstration of reasonable assurance of device safety and effectiveness.” While the FDA often requests that manufacturers provide clinical data and other documentation under what it characterizes as “related to safety and effectiveness,” it is unclear how the bill would change the way the FDA reviews medical devices in practice.

As we previously reported, another bill proposing to change the way medical devices are reviewed was recently introduced before the U.S. House of Representatives. Similar to the bill proposed by Senator Klobuchar, the House bill is aimed at increasing the efficiency of FDAs review process. However, the Senate bill differs inasmuch as it focuses primarily on expediting review for devices following the premarket approval (PMA) and 510(k) clearance pathways. Although the “Least Burdensome” provisions – the portion of the FDCA that the Senate bill seeks to change – have been in place since the passage of the FDA Modernization Act of 1997, many in the industry have found that the provisions have little effect on the FDA review process. Thus, many are hoping that the passage of the Senate bill will lead to greater efficiency by lessening the burden on manufacturers during the medical device review process.

These proposals to update FDAs medical device review process are largely a result of the report recently released by the Institute of Medicine (IOM). Published on July 29, 2011, the IOM Report contained various recommendations for the FDA in relation to its medical device review process. As we previously reported, the IOM particularly took issue with FDAs 510(k) review process, recommending that the system undergo a complete overhaul.

Fuerst Ittleman will continue to monitor the developments and changes to FDAs medical device review process. For more information, please contact us at contact@fidjlaw.com.

Seventh Circuit Finds State Consumer Protection Claim Preempted by Food, Drug and Cosmetic Act

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On October 17, 2011, the Seventh Circuit Court of Appeals affirmed a district court ruling dismissing a state law consumer fraud claim, finding that it was preempted by the Federal Food, Drug and Cosmetic Act (FD&C). The suit alleged that General Mills, Inc. and Kellogg Co. failed to disclose pertinent information concerning their “Fiber Plus” chewy bars.

In the district court case, the Plaintiff claimed that while the labeling of the product declared fiber to be 35% of the daily recommended value, this information was misleading to consumers. Because the fiber found in the product was allegedly a “non-natural,” processed fiber, providing fewer benefits than consumption of natural fiber, the Plaintiff argued that the manufacturers of Fiber Plus should have declared the origins of this fiber in labeling.

Found here, the Seventh Circuit’s Opinion discusses how state law labeling requirements may not exceed those found in the FD&C. In particular, 21 U.S.C. § 343-1(a)(5) provides that no state may establish “any requirement respecting any claim of the type described in section 403(r)(1) made in the label or labeling of food that is not identical to the requirement of section 403(r). . . .” 21 U.S.C. § 403(r) gives the U.S. Food and Drug Administration (FDA) authority to regulate nutrition labeling and related claims for food products. Taken together, these provisions prevent states from imposing and enforcing requirements that are additional to or different from those set forth by the FDA. In this case, 21 C.F.R. § 101.54(d), the FDA regulation pertaining to nutrient content claims for food, provides the requirements that manufacturers must comply with when making “fiber claims.” Reasoning that the regulation does not require a declaration of the origins of fiber in food labeling, the Seventh Circuit ultimately found the plaintiff’s state law claim preempted.

For more information regarding the labeling of food products, contact us at contact@fidjlaw.com.

Bill Proposes to Change How FDA Reviews Medical Devices

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On October 14, 2011, Representative Brian Bilbray introduced a bill before the U.S. House of Representatives, entitled the “Novel Device Regulatory Relief Act of 2011.” The Bill, which seeks to amend the federal Food, Drug and Cosmetic Act (FDCA), focuses specifically on altering the way that medical devices are reviewed by the U.S. Food and Drug Administration (FDA).

Found here, the Bill focuses on changing the FDA’s de novo review process. The de novo process is currently a separate review pathway for medical devices, created to be particularly useful for manufacturers of lower risk devices that do not require formal FDA approval via the Premarket Approval (PMA) process. Differing from the 510(k) process, de novo review may currently only be initiated after a device has been issued a Not Substantially Equivalent (NSE) letter by the FDA. In short, this means that the only devices that may seek de novoreview are those that have not been cleared via the 510(k) process. The newly introduced legislation may revamp this underutilized pathway by allowing manufacturers to submit a request for de novo review “. . . without regard to whether such person has received written notice of classification into class III.”

While the de novo review process has not proven effective in practice and has been widely criticized for lack of transparency, the FDA has been working to change the process throughout 2011. As we previously reported, the FDA recently released its plans to streamline the de novo review process, publishing its draft guidance entitled “De Novo Classification Process (Evaluation of Automatic Class III Designation),” on September 30, 2011. However, as shown in the guidance, the FDA’s plans may not have proven as effective as industry had hoped. Where the FDA had planned to introduce a process whereby a pre de novo submission (PDS) would be submitted concurrently with a 510(k) petition, it is unclear how this would have resolved the issues confronting the de novo process. Because the statutory language of the FDCA only allows for initiation of de novo review upon the issuance of a NSE letter, this new legislation may actually result in increased utilization of the de novo review process.

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.

Par Pharma Brings Suit Against FDA Over Promotional Claims

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On October 14, 2011, Par Pharmaceutical, Inc. (Par Pharma) brought suit against the U.S. Food and Drug Administration (FDA) challenging the Agencys rules that restrict claims made in marketing pharmaceutical products. Filed in the U.S. District Court in Washington D.C., the suit seeks a declaratory judgment and an injunction against the Agencys enforcement of the speech restrictions. Found here, the Complaint alleges that FDAs rules prevent Par Pharma from promoting its drug for both approved and unapproved uses.

Par Pharmas drug, Megace ES, was approved by the FDA in 2005 for the treatment of anorexia and cachexia, an AIDS-related wasting syndrome. Since its approval, the drug has been prescribed by doctors to treat other, related disorders, a practice known as “off-label” use. However, the FDA prohibits companies from promoting drugs for off-label uses, and it regularly enforces against companies which do so. For instance, the pharmaceutical manufacturer Allergan has been targeted for utilizing off-label marketing in the past. For more information regarding the Allergan suit, see our previous report here.

The FDAs jurisdiction to restrict off-label use is a contentious issue. While the FDA currently prohibits manufacturers from marketing FDA-regulated products for unapproved uses, the agency does not have the authority to prevent doctors from issuing prescriptions for off-label uses. Rather, the latter fits squarely within the practice of medicine, an area traditionally regulated by the states. Even where the FDA only attempts to restrict manufacturers without encroaching on the practice of medicine, FDAs efforts relating to off-label use are often viewed as hindering innovation inasmuch as manufacturers and doctors are prevented from discussing new, alternative uses for FDA-approved drugs and devices.

Although Par Pharma challenges the FDAs restrictions on off-label marketing, its suit also alleges that the Agency is unlawfully prohibiting the marketing of its drug for its approved uses. Specifically, Par Pharma claims that FDA is encroaching on its First Amendment rights by preventing the company from marketing its drug for its approved uses to physicians who are likely to prescribe the drug off-label. While this issue is slightly different than that regarding the promotion of off-label uses, it will be interesting to see who ultimately prevails.

For more information on FDA regulations and acceptable pharmaceutical marketing practices please contact us at contact@fidjlaw.com.

Company Pleads Guilty to Selling Misbranded Drug

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On October 14, 2011, Medisca, Inc. pled guilty to introducing a misbranded drug into interstate commerce in violation of the federal Food, Drug and Cosmetic Act (FDCA). The Complaint, which was filed on October 14, alleged that Medisca purchased a drug called “Somatropin” from China and then proceeded to distribute the drug to various pharmacies throughout the United States.

The primary issue in the case was that Somatropin, a type of human growth hormone (HGH), was being marketed as having approval from the U.S. Food and Drug Administration (FDA). According to the Complaint, the drug was not FDA approved, rendering the drug’s labeling false and misleading and therefore misbranded under the FDCA. Although it was Medisca’s contention that it possessed a valid National Drug Code (NDC) pursuant to FDA’s rules requiring every manufacturer and/or distributer to register and list all drugs in commercial distribution, the FDA warned that a NDC does not denote a drug approval. Rather, in order for drugs to be properly distributed under the FDCA and accompanying FDA regulations, a New Drug Application (NDA) must be obtained for all new drugs prior to entering interstate commerce.

Additionally, only drugs that possess an NDA may be marketed as “FDA approved.” The Office of Prescription Drug Promotion (OPDP), formerly the Division of Drug Marketing, Advertising, and Communication (DDMAC), is a division within the FDA specifically tasked with overseeing promotional claims and labeling of drugs. OPDP ensures that marketing claims are within FDA regulations and limited to what the FDA has actually approved. Further, because drugs must possess a valid NDA before lawfully being advertised as “FDA approved,” the FDA flatly prohibits other types of products, like over-the-counter (OTC) drugs and medical devices with FDA clearance, from being marketed as approved by the FDA.

For more information regarding the FDA’s regulation of drugs and the requirements pertaining thereto contact us at contact@fidjlaw.com.

U.S. Marshals Seize Detained Food under Authority of FSMA

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An illustration of FDA’s increased powers, a recent seizure was the first directed by the FDA under the authorization of the Food Safety Modernization Act (FSMA). Specifically, on October 11, 2011, the U.S. Food and Drug Administration (FDA) announced that U.S. Marshals seized food products at the FDA’s request. The food, which was being held at a storage and processing facility in Washington, was originally detained due to an infestation found during a FDA inspection. After having ordered the detention of the food products on September 2, 2011, FDA sought a warrant for the arrest of the products in federal court, ultimately resulting in the seizure.

As we previously reported, the FSMA expanded FDA’s powers in a number of areas, including those dealing with the administrative detention of goods. While FDA formerly had the authority to order the detention of goods, the Agency had to possess “credible evidence or information indicating that the article of food presents a threat of serious adverse health consequences or death to humans or animals.” 21 C.F.R. § 1.378 (2011). Today, pursuant to the FSMA, the FDA may detain foods where there is “reason to believe” that the food is adulterated or misbranded.

On May 5, 2011, the FDA issued its interim final rule, relaxing the “credible evidence” standard to require only a “reasonable basis” to believe that food is either adulterated or misbranded, and thus marking an increased burden on industry as well as the Agency. First, because the FDA must only have a reasonable basis for believing that a food is adulterated or misbranded, industry must be increasingly-vigilant in ensuring that its products are at all times compliant with FDA regulations, including the minute particularities concerning the labeling of products. Additionally, this increased power “ if fully enforced “ could strain the FDA’s overburdened resources.  

Fuerst Ittleman will continue to monitor the FDA’s measures under the FSMA. For more information regarding the FSMA or FDA regulations, please contact us at contact@fidjlaw.com or (305) 350-5690.

FDA and CMS Launch Voluntary Parallel Review for Innovative Products

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On October 7, 2011, the U.S. Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) announced the official launch of the parallel review program. An effort to increase patient access to a variety of medical devices and drugs, the program is designed to facilitate the development of innovative medical products and reduce the time between FDA approval and CMS national coverage determinations.

In September 2010, FDA and CMS announced their intentions to implement a pilot parallel review program for innovative medical devices, drugs, and biological products. Please see our previous report for more information regarding the announcement of the program. In response to the initial Federal Register Notice, the Agencies received 36 public comments regarding what products would be appropriate for parallel review, what procedures should be developed, and how a parallel review process should be implemented.

The Federal Register Notice announcing the implementation of the program details the procedures for the programs voluntary participation and guidelines for the Agencies to follow during the review of a product. The program will not change the existing separate review standards for FDA product approval and CMS coverage determinations. However, parallel review may ultimately benefit patients by expediting the time involved with the review process, as the separate determinations will run concurrently. In order to qualify for the program, product candidates must meet one of the following criteria:

  1. New technologies for which the sponsor/requester has a pre-investigational device exemption (IDE) or an approved IDE application designation;
  2. New technologies that would require an original or supplemental application for premarket approval (PMA) or a petition for de novo review; or
  3. New technologies that fall within the scope of a Part A or Part B Medicare benefit category and are not subject to a national coverage decision (NCD).

The FDA and CMS are currently accepting submissions for products seeking parallel review. The Agencies intend to perform parallel reviews for up to five products per year for the next two years, with the possibility for extension.

Fuerst Ittleman, PL will continue to monitor the progress of the FDA and CMS parallel review program. For more information on how FDA and CMS review medical products and how the parallel review process may be beneficial to your product, please contact us at contact@fidjlaw.com.

FDA Extends Comment Period for New Dietary Ingredient Draft Guidance

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On September 8, 2011, the U.S. Food and Drug Administration (FDA) announced that the comment period for its draft guidance, entitled Dietary Supplements: New Dietary Ingredient Notifications and Related Issues, will be extended until December 2, 2011. The draft guidance, issued on July 5, 2011, consists of more than 120 Q&As aimed at helping industry determine whether a dietary ingredient is a NDI, whether a notification is required, and what information should be included in the notification. Please see our previous report here for more information regarding NDIs.

Having been a controversial issue, various industry associations submitted requests for extension to the FDA, including the Natural Products Association (NPA), Council for Responsible Nutrition (CRN), United Natural Products Alliance (UNPA), American Herbal Products Association (AHPA), and Consumer Healthcare Products Association (CHPA). Additionally, the Alliance for Natural Health USA (ANH-USA) and other health advocacy groups claim that over 355,000 emails have been sent utilizing an online template to petition Congress regarding the draft guidance. Many activists view the draft guidance as a barrier to nutritional supplement access and claim the proposed regulations are beyond the scope of FDA authority. After receiving numerous requests to extend the comment period in order to provide a more comprehensive response, the FDA agreed to the extension.

Found here, the draft guidance is currently available for public comment. Fuerst Ittleman, PL will continue to monitor the progress of the draft guidance. For more information regarding the regulation of dietary supplements, please contact us at contact@fidjlaw.com.

FDA Announces Enforcement Priorities

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On September 19, 2011, the U.S. Food and Drug Administration (FDA) published its Guidance document entitled “Marketed Unapproved Drugs “ Compliance Policy Guide.” Found here, the document details the widespread availability of unapproved drugs on the market and explains the Agencys priorities with respect to enforcement. Because of the large volume of these drugs on the market and the FDAs limited resources, the Agency is forced to prioritize how it will exercise its enforcement discretion. Setting forth its highest priorities, the FDA intends to continue targeting unapproved drugs that pose significant health risks to consumers.

However, the Agency notes that it will also focus its enforcement efforts on those companies marketing unapproved drugs that are reformulated in an effort to evade FDA enforcement. As discussed in the Guidance, the FDA will consider “the timing of the change, the addition of an ingredient without adequate scientific justification (see, for example, 21 CFR 300.50 and 330.10(a)(4)(iv)), the creation of a new combination that has not previously been marketed, and the claims made,” when deciding whether to bring an enforcement action against those marketing reformulated products. While there are often legitimate reasons for a manufacturer to reformulate its product, it remains to be seen how FDA will focus its enforcement actions on only those that are reformulated in an effort to evade FDA enforcement.

For more information on FDA enforcement measures or compliance, please contact us at contact@fidjlaw.com.