FDA to Pull Nearly 250 ANDAs, Continues to Revamp Office of New Drugs

With a new year underway, the U.S.Food and Drug Administration (FDA) is doing some house-cleaning of sorts. The regulatory agency said it intends to pull nearly 250 Abbreviated New Drug Applications (ANDAs) following the failure of manufacturers to submit annual reports.

First reported by Regulatory Focus, the publication of the Regulatory Affairs Professional Society (RAPS), the FDA is pulling 249 ANDAs from the generic drugmakers. According to the report, the FDA said the manufacturers will be able to request a hearing to appeal the agency’s decision to pull the ANDAs. The manufacturing companies will have to prove the regulatory agency with a strong reason for why those ANDAs should not be pulled.

“A request for a hearing may not rest upon mere allegations or denials but must present specific facts showing there is a genuine and substantial issue of fact that requires a hearing,” the FDA said, according to the RAPS report. The FDA added that it could deny the hearing if the request from the manufacturer is incomplete or not supported by those specific facts required.

Most companies affected by the action are smaller manufacturers, such as Alra Laboratories and American Therapeutics, which have 28 and 26 proposed ANDAs set to be withdrawn, respectively. There are some larger names that can be found in the list, including Pfizer, which has two ANDAs, Valeant Pharmaceuticals, which has two, Abbott, which has two, and Fresenius USA and Sandoz, which both have on ANDA that would be withdrawn.

In addition to the pulling of the ANDAs, the FDA is also seeking input on ways to improve its Office of New Drugs. According to RAPS, companies like Pfizer, Regeneron and Amgen are weighing in on the reorganization, which was first announced in the fall. The report said the drugmakers provided input on the use of more case studies in clinical trial design, as well as the concern over inconsistent applications of the guidelines.

In its submitted comments, Pfizer said it has seen a “wide variation in actual expectations across divisions” in applying guidance to safety database. Pfizer said it has also seen inconsistencies regarding the “‘waiving’ collection/submission of non-serious adverse events for drugs that have a well-characterized safety profile,” RAPS said.

In its comments to the FDA, Regeneron remained focused on the broader use of genomic data, according to the report. The Tarrytown, N.Y.-based company said the FDA should consider using genomic information “as a component of the efficacy and safety evaluation of new drugs, and fundamentally, as a valued source of substantial evidence in regulatory decision-making,” RAPS reported.

Sanofi asked the FDA to include more analyses of data that underlies its regulatory decision-making. That way, companies can be better informed regarding their own strategies. Amgen asked for the broader sharing of “accumulated FDA experience” through the publication of FAQs or with the addition of a Q&A section on its website regarding guidance, RAPS said.

Finally, professors of health policy and economics are urging Congress to provide the FDA with greater resources to combat what they see as procedural abuses of the Orphan Drug Act. Rebecca Haffajee of the University of Michigan and Harvard Medical School’s Richard Frank wrote in the New England Journal of Medicine of the need to curb abuses of the act, such as the filing of “sham citizen petitions” that will extend the market exclusivity of drugs for rare diseases. The academic duo specifically pointed to Reckitt Benckiser’s Suboxone, a treatment for opioid addiction. The article points how Reckitt, which demerged from Indivior, the owner of the drug, abused the orphan drug status to earn billions of extra dollars through preventing other companies from marketing challengers in the U.S. Indivior has been indicted by the U.S. Department of Justice for its marketing practices.

To prevent additional abuse of the Orphan Drug Act, the duo said Congress should prohibit the “’grandfathering’ of orphan drugs and require the FDA to base qualifying economic-recoupment determinations for orphan drugs on unbiased sales projections and to revoke designations if revenues exceed projected sales,” RAPS reported. Additionally, Congress should alter the filing practices for citizen petitions, Haffajee and Frank wrote.

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