Last week, the comment period closed for the U.S. Food and Drug Administration’s (FDA) guidance document, “Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators.” This draft guidance was developed to address the FDA’s conflict of interest policy for clinical investigators who sit on advisory panels that approve drugs. If finalized, this guidance document will replace a previous version released in 2001.

This push for change is a departure from the attitude about conflicts of interest from four years ago. In 2007, the FDA tightened its conflict of interest policies to minimize industry ties that might sway or garner a panelist’s favor. At the time, the FDA determined that 10 of 32 panelists advising the FDA on a drug, Vioxx, consulted for drugmakers. Nine of those 10 panelists recommended re-introducing Vioxx into the market after the drug was pulled for concerns about heart risk. In response, the FDA strengthened their policies to prevent bias by drug reviewers.

Members of Congress have expressed interest in relaxing the FDA’s rules regarding conflicts of interest. Under the current framework, an expert may not serve on an advisory panel if the expert has any direct or indirect ties to the industry. Some members of Congress view this rule as unnecessarily restrictive and that it stymies the FDA’s approval process.

Critics of the new guidance, however, believe the FDA should try harder to find qualified experts who do not have ties to the industry. Advocates of stronger rules maintain that an investigator’s ties to the industry affect a person’s decision to approve a drug for the market.

A change in the FDA’s conflict of interest policies may impact how advisory panels are assembled and medical drugs are reviewed. Although the FDA is not bound to accept recommendations made by advisory panels, the FDA often follows their advice. This new guidance document and Congress’ pressure to relax conflict of interest policies raise interesting questions about the transparency and objectivity of the drug review process.

Fuerst Ittleman will continue to monitor the progress and status of the FDA’s conflict of interest policies. For more information, please contact us at contact@fidjlaw.com

Last week, the U.S. Food and Drug Administration (FDA) issued an official warning letter to CytoSport, Inc., the makers of the popular fortified sports drink, Muscle Milk, for mislabeling their product as “milk.” The FDA has regulatory authority to issue a warning letter, an official notice that one of the establishments products, practices, or processes has violated the Food, Drug, and Cosmetics Act (FDCA). CytoSport continues to defend the name Muscle Milk and is “proactively and openly addressing the FDAs labeling concerns.”      

Federal regulations define milk as “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows,” see 21 C.F.R. § 131.110. A product is mislabeled if it markets itself as “milk” but fails to conform to the standards set forth in the Code of Federal Regulations. According to the FDA, Muscle Milk does not meet this definition of “milk” because it is not derived from a dairy cow and contains ingredients that are not permitted by the standard.

For this reason, the FDA issued a warning letter claiming that the products use of the word “milk” is misleading to consumers. Even though the product label indicates that Muscle Milk “contains no milk,” the product does contain ingredients derived from milk, such as calcium, milk protein isolate, and whey. An allergen warning appears on the products label, but may still be misleading because it is written in smaller, less prominent writing than the word “milk.” In addition, the product poses risks to consumers who may mistakenly believe that the drink is actually free of milk-derived ingredients.

The FDA observed that the products statements of identity, the common or usual name of a food or dietary supplement, were not easily identifiable on the products label. The words “Protein Nutrition Shake” and “Nutritional Shake” appeared in much smaller and in much less prominent type than the word “milk” or the rest of the product label. In its warning letter, the FDA also pointed out that CytoSport, Inc. failed to comport with the requirements for use of the claims “healthy,” “low fat” and “low saturated fat.”

CytoSport, Inc. has 15 days to address the numerous mislabeling issues contained in the warning letter and to develop specific corrective actions. Failure to do so may put CytoSport, Inc. in jeopardy of facing product seizures or formal legal action by the FDA.

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

On May 25, 2011, the Natural Resource Defense Council (NRDC), a coalition of health and consumer organizations, filed suit against the U.S. Food and Drug Administration (FDA) regarding its regulation of antibiotics used in animal feed. The complaint alleges that the FDA has failed to withdraw the approval of antibiotics in animal feed for nontherapeutic uses that are not shown to be safe. The complaint comes as the FDAs regulation of antibiotics in food animals has been under increased scrutiny. Please see our previous report for more information regarding FDA regulation of animal antibiotics.

According to the complaint, the FDA concluded in 1977 that the nontherapeutic use of penicillin and tetracyclines in animal feed was not shown to be safe and the drugs were contributing to the development of antibiotic-resistant bacteria that could be transferred to humans. Additionally, two of the plaintiffs submitted citizen petitions, in 1999 and 2005, requesting the FDA withdraw approval. However, the agency has not issued a final response to either petition. Pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA is required to withdraw approval for animal drugs if the drugs are not shown to be safe for the uses for which they were approved. 21 U.S.C. 360b(e)(1).

The NRDC seeks to compel the FDA to take action on the agencys own safety findings, withdraw approval for most nontherapeutic uses of penicillin and tetracyclines in animal feed, and respond to the citizen petitions filed by several of the plaintiffs.

Fuerst Ittleman will continue to monitor the progress of this lawsuit and the FDAs regulation of antibiotics in animal feed. For more information, please contact us at contact@fidjlaw.com.

The Institute of Medicine (IOM) recently released a report, Medical Devices in the Publics Health: The FDA 510(k) Clearance Process at 35 Years, which summarizes the IOMs findings regarding the U.S. Food and Drug Administrations (FDA) 510(k) premarket notification program.

The FDA is responsible for ensuring that medical devices on the market are safe and effective for the publics use. In order to market a medical device in compliance with the FDAs regulations, device manufacturers must obtain either FDA approval of a premarket application (PMA) or FDA clearance of a 510(k) premarket notification. Under the 510(k) process, the FDA may “clear” a medical device if it finds that the device is as safe and effective as a predicate medical device. This 510(k) process is the pathway by which most lower-risk devices reach the market.

The FDA commissioned the IOM to review the current 510(k) program after receiving complaints from industry and consumers about the viability of the program. While reviewing the 510(k) program, the IOM was asked to consider the following two questions:

• Does the current 510(k) process protect patients optimally and promote innovation in support of public health?
• If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process optimally?

The IOM committee 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. “Premarket review, including the 510(k) process, and post-market oversight”from product labeling regulations to the reporting of adverse events associated with use of a device”make up a comprehensive medical device regulatory system.”

The committee identified substantial problems with the FDAs current post-marketing surveillance of devices. Because the FDA lacks a robust post-marketing surveillance system, the IOM recommended that the FDA “develop and implement a comprehensive strategy to collect, analyze, and act on medical device aftermarket performance information.”

Overall, the IOM committee determined that the FDAs current 510(k) process is flawed on its legislative foundation and suggested that the FDA completely overhaul its 510(k) process. “Rather than continuing to modify the 35-year-old 510(k) process,” the committee concluded that “the FDA’s finite resources would be better invested in developing an integrated premarket and post-market regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle.” In an effort to protect patients, healthcare providers, industry, and the FDA, the committee suggested that the new regulatory framework should:

• be based on sound science;
• be clear, predictable, straightforward, and fair;
• be self-sustaining and self-improving;
• facilitate innovation that improves public health by making medical devices available in a time manner and ensuring their safety and effectiveness throughout their lifecycle;
• use relevant and appropriate regulatory authorities and standards throughout the life cycle of devices to ensure safety and effectiveness; and
• be risk-based.

(For the full text of the IOMs Report Brief, click here.)

In response, the U.S. Food and Drug Administration (FDA) announced that it will request public comments on the IOMs report about the current 510(k) premarket notification process, see announcement here. Despite the IOM committees determination the current 510(k) premarket notification process is highly flawed and fails to adequately monitor the quality of medical devices on the market, the FDA maintains that “medical devices in the U.S. have a strong track record of safety and effectiveness” and, therefore, “the 510(k) process should not be eliminated.”

Jeffrey Shuren, Director of the FDAs Center for Devices and Radiological Health (CDRH), stated that “many of the IOM findings parallel changes already underway at the FDA to improve how [the FDA] regulate[s] devices.” This new plan, the CDRH Plan of Action for 510(k) and Science, is designed to improve the FDAs predictability, consistency, and transparency in reviewing medical device submissions.

For example, the FDA recently issued draft guidance clarifying when a manufacturers changes to a 510(k)-cleared device already on the market necessitate a new 510(k) clearance, as we previously reported here. In addition, the FDA intends to issue a draft guidance of the “510(k) Paradigm,” which will aim to clarify the FDAs 510(k) substantial equivalence review, and a draft guidance that strengthens and streamlines the “de novo classification” path to market for medical devices that are not substantially equivalent to an existing predicate device.

Although the FDA disagrees with the IOM committees recommendation to abandon the current 510(k) program, the Agency recognizes that certain areas are in need of improvement. For this reason, the FDA has invited the public to comment on the results of the IOMs report. In doing so, the FDA aims to find alternative proposals and approaches to help improve its device review programs.

Fuerst Ittleman will continue to monitor the developments and changes to 510(k) premarket notification process. For more information, please contact us at contact@fidjlaw.com.

Since 2006, the U.S. Department of Agricultures (USDA) Animal & Plant Health Inspection Service (APHIS) has issued over 70 decisions that deregulate genetically engineered (GE) crops, some of which include corn, soybeans, cotton, canola, alfalfa and squash. On July 1, 2011, APHIS issued another decision deregulating GE Kentucky bluegrass.

APHIS, the U.S. Food and Drug Administration (FDA), and the U.S. Environmental Protection Agency (EPA) share responsibility for regulating biotechnology products, including GE crops, to ensure that approved biotechnology products developed in the U.S. pose no risk to human health or the environment.

APHIS has stated that it does not have the authority to regulate the introduction or transportation of GE crops under the Plant Protection Act (PPA) if the crop does not present a potential for new “plant pests.” GE crops that are derived from genes or tools of microbes are subject to regulations pursuant to the PAA because they are created from plant sequences that could be potential plant pests and pose a threat to crops within the U.S. The deregulated GE crops are developed using genetic material from other plants, such as corn and rice, and contain no microbes, and therefore do not pose a threat as a potential plant pest. The USDA has stated that the decision does not represent a shift in policy and that it will make decisions on a case-by-case basis.

Critics are concerned that the deregulation of GE crops may affect the campaign for mandatory labeling of GE products. The FDA issued draft guidance in 2001 for voluntary GE labeling, but has not updated the document since. Critics of GE crops argue that consumers have a right to know what is in their food, including animal genes. Proponents of GE crops state that labels on GE food imply a warning about health effects, whereas no significant differences between GE and conventional foods have been detected. If a nutritional or allergenic difference were found in a GE food, current FDA regulations require a label to that effect. Currently, no GE foods on the market or under review contain animal genes.

For more information on current USDA, EPA, and FDA authority, procedure, or regulations regarding genetically engineered products please contact us at contact@fidjlaw.com.