Drugs

FDA Public Meeting on Generic Drug Barriers

David McFarland

— 1 min read
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FDA commissioner Scott Gottlieb says the agency will hold a 7/18 public meeting to solicit input on places where the agency’s rules, including the standards and procedures related to generic drug approvals, are being used in ways that may create obstacles to generic drug access instead of insuring the vigorous competition that Congress intended. Writing in an FDA Voice blog post, Gottlieb says the meeting is part of a new Drug Competition Action Plan intended to find ways within its authority that FDA can help address the problem of high-priced medicines.

“We know that sometimes our regulatory rules might be ‘gamed’ in ways that delay generic drug approvals beyond the time frame the law intended, in order to reduce competition,” he writes. “We are actively looking at ways our rules are being used and, in some cases, misused.”

Gottlieb cites as examples of possible misuse of regulations: 

  •          increasing unavailability of certain branded products for comparative testing, such as branded company restrictions on commercial contracts or agreements with distributors that make it hard for them to sell drugs to generic drug developers;
  •          problems accessing testing samples when branded products are subject to limited distribution through a company limit or part of a REMS (Risk Evaluation and Mitigation Strategy); and
  •          abuse of the statutory default requirement to have a single shared REMS across both branded and generic versions of a drug.

 “I want to take steps to address these concerns,” Gottlieb says, “to make sure that we are facilitating appropriate competition in circumstances where Congress intended. The forthcoming public meeting is intended to solicit public comment to inform us of circumstances where generic competition may be thwarted by these and other techniques. As we solicit additional information, we also are going to be looking at policy and programmatic changes to address these issues.”

He says the overall goal of the competition program is to broaden access to safe and effective generic drugs that can improve access to medicines and help consumers lower their healthcare costs. “As in all of the things we do,” he concludes, “we will steadfastly maintain FDA’s gold standard for rigorous, science-based regulation.”

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