PhRMA: petitions don't delay approval

Share this article:
While some attorneys and other observers say that drug companies often use citizen petitions as a means to delay the FDA approval of a generic drug after a branded company's patent has expired, Pharmaceutical Research and Manufacturers of America (PhRMA) says there is only "scant" evidence that they are filed purely to block generics.

The association says companies might take their citizen petition issues to court instead of the FDA if changes that were proposed as part of Senate FDA reform legislation take effect.

The changes would not allow a petition to delay agency approval of a generic unless delay is necessary in order to protect public health. As a check on competitors, petitioners would have to verify who is making a challenge and whether they expect to be paid for filing the petition. Congress would have to receive annual reports on delays to generics based on citizen petitions.

Share this article:
You must be a registered member of MMM to post a comment.

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...