FDA Denies Requests for Reconsideration

Aug 23, 2011   

Stemming from the recent crackdown on unapproved cough and cold drugs, the U.S. Food and Drug Administration (FDA) recently denied two citizen petitions for reconsideration of the Agencys action. Submitted by the pharmaceutical companies ECR Pharmaceuticals (ECR) and Laser Pharmaceuticals, LLC (Laser), the requests sought review of the FDAs decision to rid the market of these products without permitting the companies the opportunities for hearing and asked the Agency to stay future enforcement action, allowing their products to remain on the market until the issues were resolved. In what ultimately resulted in a dismissal based on procedural grounds, the FDA reaffirmed both its hard-line stance against these over-the-counter (OTC) unapproved medicines as well as the narrow grounds on which the Agency will allow an administrative appeal of its actions.

As we previously reported, the FDA announced early this year that it was going to begin taking action against manufacturers of unapproved cough and cold products that were formerly part of its DESI program. Beginning in the 1980s, the several unapproved drugs were temporarily exempted from FDAs standard approval process through this program because of the drugs similarities to other approved prescription drugs and OTC drugs. Under this program, the FDA allowed these products to be marketed and sold until final DESI determinations were made. Until early this year, when FDA announced it was ending the exempt status of these drugs, many of these drugs remained on the market.

Seeking to prevent future enforcement action against them, ECR and Laser sought hearings from the FDA concerning the safety and effectiveness of the companies respective OTC drugs. Having denied the requests, the companies then each sought reconsideration of FDAs decision to abruptly end their exempt statuses under the DESI program.

Ultimately, the FDA denied both petitions on procedural grounds, citing to the Agencys regulations as limiting the scope of administrative reconsideration to certain specified matters. Referring to its regulations in its denials, the FDA noted that “[t]he Agencys regulation on reconsideration at 21 CFR 10.33 provides that a person may request reconsideration of FDA decisions on certain types of petitions formally submitted to the Agency.”

Provided in this regulation are the matters that may be subject to administrative reconsideration. Under 21 CFR 10.25, the types of actions amenable to administrative reconsideration are listed and include: new drug applications, color additive petitions, etc. Additionally, these actions include citizens petitions requesting that the FDA issue, amend, or revoke a regulation, as well as refraining from taking any other form of action. While the text of the regulation does not provide an exhaustive list of the types of action that may be the subject of administrative reconsideration, these recent denials have made it clear that the FDA is interpreting the availability of this form of review very narrowly.

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