Regulatory Focus™ > News Articles > US Regulators Give Final Shot to Owners of Unapproved Drug Products

US Regulators Give Final Shot to Owners of Unapproved Drug Products

Posted 23 July 2012 | By Alexander Gaffney, RAC 

Don't have approval for your drug product? For a small number of manufacturers covered by unusual circumstances, the US Food and Drug Administration (FDA) is granting one last shot to obtain a request for a hearing and potential approval.

In a 23 July Federal Register notice, the agency highlights certain drug products that could have been marketed extensively under now-outdated provisions in federal law.

Between the passage of the 1938 Federal Food, Drug and Cosmetic Act (FD&C Act) and the 1962 Kefauver-Harris Amendments, drugs could obtain approval if they were identical, related or similar (IRS) to a drug approved for marketing. The 1962 amendments established the need to prove a product's efficacy, while the 1938 act only required a drug be shown to be safe before being allowed on the market.

FDA subsequently contracted with the National Academy of Sciences and the National Research Council to evaluate drugs legally on the market but not approved by the agency. The effort, called the Drug Efficacy Study Implementation (DESI), classified as "New Drugs" all products covered by the review, and any product marketed as IRS were subsequently classified as unapproved new drugs.

Products could submit supplemental applications to FDA relying on DESI's findings of effectiveness for a given indication, but would require approval from FDA in order to market the drug product legally.

As part of FDA's 2006 Unapproved Drugs Initiative, the agency said it would begin a systematic review of all drugs remaining on the market nearly 50 years after the start of the DESI program to determine if-or how many-drugs remained on the market under an IRS indication.

The 23 July Federal Register notice identifies nine outstanding hearing requests initiated by companies, and asks that the companies covered by the requests either respond to the agency directly or withdraw or affirm its hearing request. Because some of the requests may pertain to companies no longer in business, FDA said it plans to withdraw any requests that don't respond to its Federal Register notice within 30 days.

Several companies, including Pfizer, Valeant Pharmaceuticals, Apotex, Copley Pharmaceutical, and Actavis U.S., are noted by FDA to still have outstanding hearing requests. Many of the companies are recipients of the IRS drugs by way of mergers, the agency explained. It remains unclear if any of the companies currently manufacture the products in question.

Read more:

FDA - Drugs for Human Use; Drug Efficacy Study Implementation: Certain Prescription Drugs Offered for Various Indications; Opportunity to Affirm Outstanding Hearing Request

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