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# FDA to Help With Legislation to Curb Generic Drug Delays
- URL: https://www.fdaweb.com/fda-to-help-with-legislation-to-curb-generic-drug-delays/
- Published: 2016-09-22T12:00:00.000Z
- Updated: 2026-09-14T21:34:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136892

FDA is interested in providing technical expertise on legislation that could curb brand name drug companies’ efforts to block or delay generic drug entry into the market, but it says any measure should be crafted with care to avoid any unintended consequences. During a Senate appropriations subcommittee hearing 9/21, CDER director **Janet Woodcock** told Sen. **Susan Collins** (R-ME) that the agency is worried about these delay tactics, particularly those that use restricted distribution programs to prevent generic companies from obtaining drug quantities to conduct necessary bioequivalence testing. The hearing was called to examine FDA’s role in the generic drug marketplace, and was motivated by attention given to Mylan’s pricing on EpiPen.

“We have received over 100 inquiries from generic companies about problems getting a reference-listed drug due to restricted-distribution programs,” Woodcock told the hearing. “Sometimes these programs are a part of a Risk Evaluation and Mitigation Strategy (REMS), and other times brand companies have restricted distribution outside of a REMS, and clearly this is impeding the ability to obtain enough drug to compare. With respect to what can be done by Congress, we remain concerned that many of the drugs are so valuable that companies will do a great deal to delay generic competition.”

Woodcock said the agency is concerned that any type of proposed legislation that would have a lot of extra steps for the agency to follow would be troublesome. She said that each provision in any legislation would be used as an opportunity by brand drug makers to sue or file a petition challenging the agency’s interpretation and implementation, which would ultimately create more delays for generic drug entrants. And penalties or fines “might simply be seen as the cost of doing business because there is so much at stake in delaying generic competition,” she added.

Collins said Congress is also interested in examining more closely the effect “authorized generics’ have on potential generic competitors from entering the market. Woodcock said that to date the agency has been notified on 980 authorized generics that are on the market — “so it appears to be a relatively common practice in the industry.” Collins underscored that this area “does need more examination as far as its impact on discouraging a true first generic or second generic to come onto the market.”

Early this year, Collins introduced the Increasing Competition in Pharmaceuticals Act [(S. 2615)](https://www.congress.gov/bill/114th-congress/senate-bill/2615/text?ref=fdaweb.com) to increase generic drug competition by improving the review and approval of ANDAs and establishing a clear timeline for FDA to expedite review of certain applications for generic drugs. Sections in the bill say their provisions would improve generic access, require a report on pending generic drug applications, provide for a generic priority review voucher, improve review of tropical disease product applications, and authorize a study of REMS.

During her testimony, Woodcock also noted that under the next generic drug user fee reauthorization, the agency will look to implement a program for providing advice for sponsors seeking to market complicated generics before companies apply. “That’s something there’s great interest in,” she said, adding that this has been a very successful advice program for new drugs. Additionally, she said the agency will be looking to identify common problems in generic drug submissions in order to increase first-cycle approvals. Before the generic user fee program was put in place four years ago, hardly any submissions made it through first cycle and normally it would take four review cycles to reach approval.

In conclusion, Woodcock told the subcommittee FDA is very focused on getting important drugs to market and making sure pathways are clear and there are not unnecessary barriers to getting on market. “Our standards have to do with making sure those drugs work for patients and they are reasonably safe and they are of adequate quality,” she said. “We do expedited reviews where we can to improve availability and we are sensitive to that.”