FDA Releases Factors for Determining High-Risk Status for Domestic Food Facilities

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As we previously reported, the FDA Food Safety Modernization Act (“FSMA”) created many new obligations for both U.S. Food and Drug Administration (FDA) and the food industry. One such obligation is found in section 201 of the FSMA, “Targeting of Inspection Resources for Domestic Facilities, Foreign Facilities, and Ports of Entry.” This section requires that FDA inspect food facilities at a frequency based upon a facilitys status as either high-risk (“HR”) or non-high-risk (“NHR”). FDA has just published FDA Domestic Facility Risk Categorization for FY 2012, which sets out the criteria FDA will be using to determine whether a domestic food facility is HR or NHR.

Status as either HR or NHR will determine a food facilitys frequency of inspection by FDA. HR facilities must be inspected at least once in the first five years following enactment of the FSMA and then once every three years thereafter. NHR facilities, on the other hand, must be inspected only once in the first seven years following enactment of the FSMA and then once every five years thereafter. These are minimum guidelines and some facilities may be inspected more frequently.

In the FDA Domestic Facility Risk Categorization for FY 2012, FDA is identifying HR food facilities based on the six risk factors identified in section 421(a)(1) of the Food, Drug, and Cosmetic Act (“FDCA”), which are as follows:

  • The known safety risks of the food manufactured, processed, packed, or held at the facility;
  • The compliance history of a facility, including with regard to food recalls, outbreaks of foodborne illness, and violations of food safety standards;
  • The rigor and effectiveness of the facilitys hazard analysis and risk-based preventive controls;
  • Whether the food manufactured, processed, packed or held at the facility meets the criteria of priority under section 801(h)(1) of the FDCA, which relates to the prioritization to detect intentional adulteration in food offered for import into the U.S.;
  • Whether the food or the facility that manufactured, processed, packed, or held such food has received a certification as described in section 801(q) (for imported foods only) or 806 (voluntary qualified importer program) of the FDCA, as appropriate; and
  • Any other criteria deemed necessary and appropriate by the FDA for purposes of allocating inspection resources.

However, for Fiscal Years (FY) 2011-13 for domestic food facilities, FDA is determining of whether a domestic food facility is HR based upon the following four factors:

  • The known safety risks of the food manufactured, processed, packed, or held at the facility. The “known safety risks” of food “are based on broad, industry-level food commodity categories, e.g., bakery, leafy vegetables, spices.”
  • The compliance history of a facility, including with regard to food recalls, outbreaks of foodborne illness, and violations of food safety standards. The “compliance history” of a facility is “based on inspection results for a facility from the previous five fiscal years.” Specifically, facilities with a history of non-compliance with food safety requirements, i.e., a history of three or more “Voluntary Action Indicated” (“VAI”) within the five year time period, and those facilities with food safety violations of regulatory significance, i.e., one or more “Official Action Indicated” (“OAI”) in the five year time period, will be categorized as an HR facility.
  • The type of establishment and type of activity conducted at the facility (e.g., manufacture/processor, repacker/packer, etc.)
  • The number of years since the last inspection.

The last two factors have been identified as “other criteria deemed necessary and appropriate” for purposes of allocating inspection resources.

As FDA implements the FSMA and gathers more information, FDA will most likely need to make modifications and adjustments for FY 2014. At this time, food facilities should begin to evaluate any known safety risks associated with the food they manufacture, process, pack or hold and understand whether they are likely to be categorized as HR or NHR.

Please contact us at (305) 350-5690 or contact@fidjlaw.com to learn more about how FDA may categorize your food facility or if you have any questions regarding FSMA.

Update: Court Rules that FDA’s Graphic Smoking Warning Labels Violate First Amendment

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On February 29, 2012, Judge Richard Leon of the United States District Court for the District of Columbia issued an Order finding that the FDAs new graphic cigarette warning labels are a violation of the First Amendment and therefore unconstitutional. A copy of the Courts opinion can be read here.

As we previously reported, on June 21, 2011, pursuant to the authority granted to it by the Family Smoking Prevention and Tobacco Control Act to regulate tobacco, the FDA issued a final rule that requires each cigarette package and advertisement to bear one of nine new textual warning statements and an accompanying graphic image (see FDAs approved images here).  Additionally, the rule required these warnings to appear on every pack of cigarettes sold in the US and in every cigarette advertisement starting no later than September 2012.

As we reported here,< on August 16, 2011, five tobacco companies filed a complaint against the U.S. Food and Drug Administration (FDA) in the U.S. District Court for the District of Columbia challenging the Agencys rule requiring new textual and graphic warning labels on cigarette packaging and advertisements. The five tobacco companies (R.J. Reynolds Tobacco Company, Lorillard Tobacco Company, Commonwealth Brands, Inc., Liggett Group LLC, and Santa Fe Natural Tobacco Company, Inc.) sought a declaratory judgment that the FDAs final rule violates the First Amendment and Administrative Procedure Act (APA), and declarative and injunctive relief that the new textual and graphic warnings not become effective until 15 months after FDA issues regulations "that are permissible under the United States Constitution and federal laws."

On November 7, 2011, Judge Leon granted a preliminary injunction in favor of the five tobacco companies finding that the tobacco manufacturers had a substantial likelihood of success on the merits of their constitutional and APA challenges because the FDAs labeling requirements are likely violative of the First Amendment. Our complete report on the Courts preliminary injunction can be read here.

In its Complaint, the tobacco companies alleged that the requirement to place graphic images on its labels unconstitutionally compels speech. Generally speaking, compelled speech is presumptively unconstitutional and will only be upheld if it passes “strict scrutiny,” i.e.: 1) the government has a compelling interest it seeks to protect; and 2) the regulation is narrowly tailored to achieve that interest. However, as explained by the Court, narrow exceptions apply in the area of commercial speech. The government may require disclosure of only “purely factual and uncontroversial information” to protect consumers from “confusion or deception,” unless such a disclosure is “unjustified or unduly burdensome.” A lower level of scrutiny applies in cases where government- compelled speech meets this narrow exception. See generally Zauderer v. Office of Disciplinary Counsel of Sup. Ct. of Ohio 471 U.S. 626 (1985).

In granting the tobacco companies motion for summary judgment, the Court first determined that the FDAs rules did not meet the narrow exception for compelled commercial speech. The Court found that the images were not designed to protect consumers from confusion or deception. Rather, “they were crafted to evoke a strong emotional response calculated to provoke the viewer to quit or never start smoking.” Thus, the Court found that objective and purpose of the warnings were not the dissemination of purely factual and uncontroversial information. Therefore, strict scrutiny and not a lower, more deferential standard applied.

Here, when evaluating whether the FDAs labeling rule passed constitutional muster, just as the Court noted when it granted the tobacco companies preliminary injunction, the Court found that regardless of whether the governments asserted interests were compelling, the FDAs rule is not narrowly tailored to achieve such a purpose. The Court found that “the sheer size and display requirements for the graphic images,” (the top 50% of the front and back of all cigarette packages manufactured and distributed in the US), were not designed to achieve an informative purpose. Instead, the Court found that the dimensions were designed to promote a government sponsored anti-smoking agenda.

Furthermore, the Court found that the Government could achieve its purpose of educating the public on the risks of smoking by using several less restrictive and burdensome alternatives, each of which would not unconstitutionally compel speech. These alternatives include: 1) an increase in anti-smoking advertisements disseminated by the Government; 2) increases in cigarette taxes; and 3) improved efforts by the Government to prevent the unlawful sale of cigarettes to minors. Additionally, the Court found that less restrictive and burdensome alternatives existed for the proposed warnings themselves such as “reduc[tion] [of] space appropriated for the proposed Ëœwarnings to 20% of the packaging or require[ing] Ëœwarnings only on the front or back of the packages,” and using “graphics that convey[] only purely factual and uncontroversial information rather than gruesome images designed to disgust the consumer.”

In addition to finding the current FDA labeling rules unconstitutional, the Court also issued a permanent injunction enjoining the FDA from enforcing any textual and graphic warnings required by the Tobacco Control Act until 15 months after the issuance of new regulations which are compliant with the U.S. Constitution and federal law. Fuerst Ittleman will continue to monitor the FDAs regulation of tobacco products and advertising. For more information, please contact us at contact@fidjlaw.com. 

FDA Denies Citizen Petition Seeking Mandatory NDA Labeling for Prescription Drugs

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On January 6, 2012, the U.S. Food and Drug Administration (“FDA”) denied a citizen petition (Docket No. FDA-2008-P-0291) requesting the FDA to require manufacturers and distributors of prescription drug products to include the new drug application (“NDA”) number on drug product labels.

PRN Publishing, a company that distributes a monthly newsletter for community pharmacists, filed this citizen petition in 2008 over concerns about pharmacists ability to determine the equivalency status of prescription drug products. (See the full text of PRNs citizen petition here.) When filling prescriptions, pharmacists often refer to the list of Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book, to determine the equivalence status of brand and generic drug products in the United States. Where substitution is not prohibited by a prescriber, pharmacists have a duty to dispense only those generic products which appear in the Orange Book and are rated “A.” The citizen petition argued that, due to frequent changes in drug manufacturers and distributors of particular drugs, pharmacists may have difficulty matching drug products on the shelves with the corresponding listing in the Orange Book. As a solution, PRN suggested that all prescription drug manufacturers and distributors should include a drug products NDA number on the label of each bottle. Thus, this system would allow pharmacists “to quickly and easily determine the equivalence status of any drug product by simply comparing the NDA number on the bottle to the NDA numbers listed in the Orange Book under the heading of the particular drug in question.”

Currently, 21 C.F.R. part 314 requires that all drug manufacturers obtain FDA approval of a drug application in order to market a new drug or generic drug. Manufacturers and distributors, however, are not required to place this approved application number on drug product labels. Section 10.30 of the Code of Federal Regulations provides citizens the opportunity to submit a petition to the FDA requesting the Agency to add, remove, or change its regulations. (See 21 C.F.R. § 10.30.) In its citizen petition, PRN suggested that the change to Agency requirements would benefit all stakeholders because it would 1) protect patients from inadvertent illegal substitution; 2) relieve pharmacists of the undue burden of having to research the provenance of each drug product before dispensing generics; and 3) guarantee drug makers that a companys NDA is “firmly attached to its product in whatever form it is distributed.”

Upon reviewing this citizen petition, the FDA did not find PRNs recommendation to be an effective means of communicating drug equivalence to pharmacists. (See the full text of FDA denial here.) In its denial, the FDA pointed out that authorized generic drugs share the same NDA numbers as the branded innovator product and would not be identified separately from the branded drug in the Orange Book. The FDA addressed this issue in the introductory section of the 28th edition of the Orange Book. There, the FDA specifically indicated that distributors and repackagers of products in the Orange book are not identified “because [they] are not required to notify FDA when they shift their sources of supply from one approved manufacturer to another.” Consequently, “it is not possible to maintain complete information linking product approval with the distributor or repackager handling the product.”

Further, the FDA asserts that PRNs recommendation may result in confusion because “[p]harmacists could be confused when they look up an NDA number in the Orange Book and find only a listing for the innovator product.” The FDA noted that the citizen petition lacked sufficient data or information to support the claims listed. After balancing PRNs claims against the Agencys statutory mandate, space limitations, alternatives, potential for confusion, and potential safety risk, the FDA concluded that it would not be necessary to amend the current drug labeling requirements at this time and denied PRNs citizen petition.

Fuerst Ittleman will continue to monitor the developments in the regulation of drug products. For more information, please contact us at contact@fidjlaw.com. 

FDA Fines American Red Cross for Blood Safety Violations

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After conducting inspections of American Red Cross facilities between April 2010 and October 2010, the FDA found that 16 blood collection sites did not meet the FDAs standards for safety. These “significant violations” included inadequate managerial control, record-keeping and quality assurance. According to the FDA, however, the lapses did not lead to serious health consequences for blood recipients. The Red Cross has announced that it has taken corrective action to address the FDAs concerns. On January 18, 2012, the U.S. Food and Drug Administration (FDA) fined the American Red Cross $9.59 million for failing to comply with blood safety regulations.

The FDA, through the Center for Biologics Evaluation and Research (CBER) and Office of Regulatory Affairs (ORA), is responsible for the regulation of the collection of blood and blood components used for transfusion or for the manufacture of pharmaceuticals derived from blood and blood components.  Pursuant to Section 351 of the Public Health Service Act (“PHS Act”) and the Food, Drug, and Cosmetic Act (“FDCA”), the FDA oversees and enforces quality standards, conducts inspections of blood establishments, and monitors reports of errors, accidents and adverse clinical events.

The FDA inspects blood establishments to ensure that products are manufactured safely and in a way that protects the purity, potency and quality of the blood products. In addition, the FDA requires blood establishments to properly screen donors, maintain good manufacturing practices (cGMPs), maintain accurate records, investigate any breaches of establishment safeguards, and correct system deficiencies. Licensed blood facilities may engage in the sale, transport, and exchange of blood and blood products across state lines.

Failure to comport with the FDAs regulations may result in enforcement action in the form of a fine, as in the Red Crosss case, regulatory action letters, or revocation of establishment licensure.  In previous years, the FDA has entered into Consent Decrees with several blood bank establishments, such as the American Red Cross and the New York Blood Center, for violations of cGMPs and inadequate quality assurance programs. The FDA has also suspended the license of a blood center (Intermountain Health Care) due to numerous cGMP violations. Although the FDA has expressed its continued commitment to upholding high standards for blood collection and blood bank establishments, the onus of compliance with the FDAs regulations and the safety of the nations blood supply rest in the hands of the individual blood establishments.

Fuerst Ittleman will continue to monitor the FDAs regulation of biologics products and establishments. For more information, please contact us at contact@fidjlaw.com

FDA Exempts Certain In Vitro and Radiology Devices from 510(k) Requirements

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On December 20, 2011, the U.S. Food and Drug Administration (FDA) published guidance entitled “Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices.” The guidance exempts certain Class I and Class II in vitro and radiology devices from premarket notification (510(k)) requirements. A complete list of the specified devices can be found in the guidance document. The FDA received five public comments on the draft guidance that was published on July 12, 2011. Please see our previous report for more information regarding the draft guidance document.

The FDA classifies medical devices based on perceived risk using a 3-tier system. Class I medical devices have the lowest perceived risk, and generally do not require a formal FDA review before marketing. Class II medical devices have a higher perceived risk than Class I, and require the submission of a 510(k) or premarket notification application (PMA) to establish the safety and effectiveness of the device. Class III medical devices have the highest perceived risk, and require the submission of a PMA. The Agency believes the safety and effectiveness of the newly exempt devices is sufficiently well established and a 510(k) review is not necessary.

The guidance states that the FDA intends to propose an amendment to the classification regulations to exempt the specified Class I devices from the 510(k) requirements that apply pursuant to section 510(I) of the Federal Food, Drug, and Cosmetic Act. In addition, the FDA intends to propose the downclassification and exemption from the 510(k) requirements for the specified Class II devices. The FDA states that the in vitro and radiology Class II devices now receiving a 510(k) exemption are sufficiently well-established and have sufficiently controlled the risks that are necessary to assure the safety and effectiveness; thus, those devices can now be reclassified as Class I. In the interim period while the FDA finalizes such exemption and downclassification, the FDA intends to exercise enforcement discretion with regard to 510(k) submission requirements for the devices listed in the guidance.

The FDAs review of medical devices through the 510(k) process 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.

FDA Provides Guidance on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices

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Last month, the U.S. Food and Drug Administration (FDA) issued a draft guidance on the issue of responding to unsolicited requests for information about off-label use of prescription drugs and medical devices. (For the full text of the draft guidance, click here.) As we previously reported here, manufacturers and distributors of medical drugs and devices have pushed the FDA to release more concrete guidance on communications pertaining to off-label use, especially in light of the rapid growth of the internet and other social media tools and technologies. Off-label use occurs when a healthcare professional prescribes a product for a use or treatment indication not included in the products approved labeling. This draft guidance is aimed to specifically address solicitations for information received by product manufacturers regarding off-label indications or conditions of use.

The draft guidance clarifies the difference between unsolicited and solicited requests, and also differentiates between requests that are public and non-public. Solicited requests are requests for information that are “prompted in any way by a manufacturer or its representatives.” According to the draft guidance, the FDA may consider a solicited request as evidence of a firms intent to support or market a drug or medical device for a condition or use that has not been approved by the FDA.

Unsolicited requests, on the other hand, are “initiated by persons or entities that are completely independent of the relevant firm.” A public unsolicited request is made in a public forum. A question about off-label use of a specific product during a live presentation is one example of a public unsolicited request. A non-public unsolicited request is directed privately to a firm using a one-on-one communication approach. An example of a non-public unsolicited request is a call or e-mail for off-label use to medical information staff at a firm.

The FDA remains committed to its long-standing position that “firms can respond to unsolicited requests for information about FDA-regulated medical products by providing truthful, balanced, non-misleading, and non-promotional scientific or medical information that is responsive to the specific request, even if responding to the request requires a firm to provide information on unapproved or uncleared indications or conditions of use.” For any response made to a non-public unsolicited request for off-label information, the FDA recommends that a firm provide information only to the individual making the request. In addition, the information contained in the response should conform to the following:

– Information should be tailored to answer only the specific question(s) asked;

– Information should be truthful, non-misleading, accurate, and balanced;

– Information should be scientific in nature; and

– Information should be generated by medical or scientific personnel, independent from sales or marketing departments. 

In addition, the distributed information should be accompanied with a copy of the FDA-required labeling, a statement disclosing the indications for which the FDA approved or cleared the product, and a statement notifying the recipient that the FDA has not approved or cleared the product as safe and effective for use. If a firms response conforms to the FDAs new draft guidance, the FDA would not use the response as evidence of the firms intent to unlawfully support or market the product for an unapproved or uncleared use.

The FDA also addressed responses to public unsolicited requests for off-label information made through electronic media. Although the FDA recognizes that addressing off-label use to the general public can result in potential benefits to the public health, the agency continues to have significant concerns about broad, public responses. First, the FDA is concerned that product information posted on websites or other public forums may provide information about off-label use to individuals who have not requested such information, and would thus promote a product for a use or condition not approved or cleared by the FDA. Secondly, the FDA is concerned that the information posted on websites or other public forums would be available for an indefinite amount of time, and could pose a serious risk to public safety if new scientific advances render the posted information outdated or obsolete. Based on these concerns, the FDA recommends that firms only respond to requests pertaining specifically to its own named product. Further, firms should omit any information pertaining to off-label usage, should provide the individual requesting information with the firms contact information, and should recommend that the individual contact a medical/scientific representative with the specific unsolicited request to obtain more information. Any public response should disclose a representatives relationship to the firm and should not be promotional in nature. 

In addition to this draft guidance, the FDA also issued a notice in the Federal Register on December 28, 2011, announcing the comment-period for scientific exchange. (For the full text of this notice, please click here.) At present, FDA regulations do not restrict the promotion of the “exchange of scientific information” regarding an investigational drug or device. The FDA, however, has yet to define the scope of scientific exchange. This notice, a direct response to a Citizen Petition jointly filed by several major pharmaceutical manufacturers, seeks comments on all aspects of scientific exchange communications and activities related to off-label uses of marketed drugs, biologics, and devices and use of products that are not yet legally marketed.

Specifically, the FDA seeks comments on how “scientific exchange” should be defined, what types of activities fall under scientific exchange, how to determine the players involved in scientific exchange, how it should be distinguished from promotion, and how the FDA should treat scientific exchange for products that have not been approved or cleared by the FDA. These comments will help the FDA to evaluate its policies on off-label uses and possible pre-approval communications. The FDA will accept comments through March 27, 2012.

Fuerst Ittleman will continue to monitor any developments in the FDAs regulation of off-label uses for medical drugs and devices. For more information, please contact us at contact@fidjlaw.com.

FDA and FTC Team up to Target HCG Weight Loss Products

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On December 6, 2011, the U.S. Food and Drug Administration (FDA) announced the issuance of seven Warning Letters to companies marketing human chorionic gonadotropin (HCG) products for weight loss. Found here, the announcement highlights the various ways in which current marketing of these products is not compliant with federal law.

First, because these products are intended for use in the diagnosis, cure, mitigation or treatment of disease, they are considered drugs by the FDA. Noting that HCG is a FDA-approved prescription drug, FDA has found that these products are “new drugs” within the meaning of the Federal Food, Drug & Cosmetic Act (FDCA). Under the FDCA, a “new drug” is defined as:

[a]ny drug . . . the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the condition prescribed, recommended, or suggested in the labeling thereof.

21 U.S.C. § 321(p).

In targeting these HCG diet products, the FDA has determined that they constitute “new drugs” under the FDCA because companies marketing the products do not possess any evidence showing that the drugs are recognized as safe for their intended uses.

Further, with cooperation from the Federal Trade Commission (FTC), the agencies have targeted these companies for making unsubstantiated claims regarding the effectiveness of HCG products. While both agencies require that promotional statements be truthful and non-misleading, the recent Warning Letters allege that these companies do not possess the necessary scientific evidence to support their weight loss claims.

Under the FTC Act, the FTC has shared jurisdiction with the FDA over claims made in the marketing of FDA-regulated products. Thus, when FDA-regulated products, like the HCG diet products in the present circumstances are at issue, the agencies often work together to target non-compliant parties, with both being able to require companies to take corrective action. For more information about FDA and FTC cooperative efforts, see our previous report here.

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

FDA Issues Two Draft Guidances Regarding Investigational Device Exemptions

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On November 10, 2011, the U.S. Food and Drug Administration (FDA) issued two new draft guidance documents regarding Investigational Device Exemptions (IDE) applications for early feasibility studies and clinical investigations. The Agency seeks to foster early-stage development of medical devices in the United States, contribute to medical research, and address important clinical needs to improve patient care.

An IDE allows investigational devices to be used in feasibility or clinical studies in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to the FDA. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE
before the study is initiated. 21 CFR 812. Please see our previous report for more information concerning PMA and 510(k) submissions for medical devices.

Draft Guidance for Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies

The draft guidance regarding IDE applications for early feasibility studies applies to medical devices of significant risk in the early stages of development. Early feasibility studies allow for early clinical evaluation of devices to provide proof of principle and initial clinical safety data to better inform the final design of the device. The guidance permits studies to start earlier in the device development process than previously allowed. However, initiation of early feasibility studies must be justified by a risk-benefit analysis and adequate human subject protection measures. The new draft guidance also permits select device modifications to be made without FDA approval.

FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations
The draft guidance regarding IDE applications for clinical investigations clarifies the FDA’s process for approving clinical trials of medical devices. The draft guidance describes the Agencys methods which allow clinical investigations of devices to begin under certain circumstances even when there are outstanding issues regarding the IDE application. Those methods include: approval with conditions, staged approval, and communication of outstanding issues related to the IDE through future considerations.

The FDA permits an IDE application that receives an approval with conditions to enroll patients in studies while certain issues are being resolved. Those issues may include: data analysis methods that can be resolved prior to gathering the data, minor divergences from study endpoints, or study design assumptions. A staged approval allows studies to begin with a smaller group of subjects while applicants gather additional data, prior to beginning larger general enrollment.

Fuerst Ittleman is well-equipped to assist members of FDA-regulated industry navigate the laws and regulations applicable to medical devices. For more information about the current regulatory framework surrounding medical devices, please contact us at contact@fidjlaw.com.

Merck Agrees to $950 Million in Fines for Unlawful Promotion of Vioxx

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On November 22, 2011, the U.S. Justice Department announced that Merck had agreed to a settlement of $950 million in connection with the allegedly unlawful promotion of the painkiller Vioxx. Found here, the criminal information details the charges against Merck, showing how the companys promotional practices resulted in a violation of the Federal Food, Drug and Cosmetic Act (FDCA). In November 1998, Vioxx was approved for the relief of symptoms associated with osteoarthritis, treatment of dysmenorrheal and general pain management. On April 11, 2002, the U.S. Food and Drug Administration (FDA) approved Vioxx for the treatment of rheumatoid arthritis, an additional indication. However, in its case against Merck, the Government alleged that the company had been promoting Vioxx for the treatment of rheumatoid arthritis long before it had been approved for this use. According to the Government, this unlawful off-label promotion by Merck resulted in a violation of the FDCA, as Vioxx was considered misbranded under the Act. Ultimately, Merck agreed to plead guilty to a misdemeanor and $950 million in fines.

In the Merck case, because the company was actively involved in marketing Vioxx for uses that were not approved by the FDA, it was charged with introducing a misbranded drug into interstate commerce. Under 21 U.S.C. § 352(f)(1) a drug is deemed misbranded if it fails to bear adequate directions for use. Under the FDCA and its accompanying regulations, the FDA approves drugs for specific uses by requiring sponsors to submit data showing drugs are safe and effective for their intended uses and limits the promotion of drugs to these specified uses by approving proposed labeling. Because Vioxx was promoted for a use not shown in the product labeling, it was considered misbranded by the FDA as the label failed to display this indication and thus lacked adequate directions for use.

For more information about the FDA drug approval process, please contact us at contact@fidjlaw.com.

FDA Initiates Enforcement Against Dietary Supplement Manufacturer

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On November 23, 2011, the U.S. Food and Drug Administration (FDA) announced the initiation of enforcement measures against a dietary supplement manufacturer, charging the company with several violations of the Federal Food, Drug and Cosmetic Act (FDCA). The FDAs complaint seeks a permanent injunction aimed at preventing ATF Fitness Products, Inc. (ATF) from continuing to sell its products. The complaint alleges that over 400 of ATFs dietary supplement products are in violation of the FDCA.

While this suit was recently instituted against ATF, the Complaint shows how the company has been on FDAs radar since 2004. According to FDA, ATF has “a long history of violating the Act.” In March 2004, FDA issued a Warning Letter to the Company in connection with its distribution of an adulterated dietary supplement. Later, in November 2004, FDA issued another Warning Letter, citing the president of ATF for the distribution of adulterated dietary supplements. Finding that ATF was not taking proper corrective actions to remedy these violations, the warnings ultimately culminated in a seizure action in 2006, detailed here. The most recent FDA action began after a FDA inspection conducted in March-April 2011 revealed several deviations from FDAs current good manufacturing practices (cGMPs). In particular, FDA found that several ingredients and products were being substituted during the manufacturing process without the changes being reflected in product labeling.

In addition to cGMP violations, FDAs inspection also revealed that ATF failed to report serious adverse events. Under 21 U.S.C. § 379aa-1, manufacturers of dietary supplements are required to notify the FDA within 15 days of learning of a serious adverse event. A serious adverse event is defined under the Act as an event that results in:

(i) death; (ii) a life-threatening experience; (iii) inpatient hospitalization; (iv) a persistent or significant disability or incapacity; or (v) a congenital anomaly or birth defect.

21 U.S.C. § 379aa-1(a)(2).

According to the FDA, ATF received a complaint that one of its customers had experienced a spike in blood pressure and mild heart attack, requiring hospitalization. Despite having received this complaint in July 2010, ATF did not report this event, resulting in what FDA claims was another violation of federal law.

Given the past violations of the FDCA and the several deficiencies discovered upon the recent inspection, FDA ultimately instituted the present action against ATF. While warning letters are not uncommon, the remedial measures that companies take in response to them are often determinative of how the FDA will proceed.

For more information about FDA enforcement action or regulatory compliance, please contact us at contact@fidjlaw.com.