FDA’s Generics Backlog Is Hurting Competition, Lawmaker Says

Sen. David Vitter is asking the FDA to process its current backlog of more than 3,000 generic drug applications, especially in light of recent prescription drug price increases.

Vitter (R-La.) sent a letter to FDA Acting Commissioner Stephen Ostroff on Sept. 28 citing, among other cases, Turing Pharmaceuticals’ decision to raise the per-tablet cost of Daraprim (primethamine) to $750, from $13.50, a month after purchasing the decades-old medication from Impax Laboratories.

“The bottom line is that this extensive backlog serves as a major obstacle to a market-based, competitive response to manufacturers who choose to run up prices,” Vitter writes.

In July, Vitter introduced the Safe and Affordable Prescription Drugs Act of 2015, S. 1790, which would allow consumers to import U.S.-made prescription medicines from approved pharmacies in other countries to reduce prices here. The bill has been sent to the Senate HELP Committee.

Earlier this year, generics industry groups called for major changes to the Generic Drug User Fee Act program when it is reauthorized in fiscal 2018, citing slower review times and a decline in approvals (Generic Line, June 24).

The FDA did not comment on Vitter’s letter. Read the letter here www.fdanews.com/10-07-15-vitterletter.pdf. — John Bechtel

 

 

$1,097 $847

Bonus

Subscribe to Generic Line and save $250 off the regular one-year price of $1,097 — plus receive a FREE copy of our webinar, Success Strategies for Biosimilars Approval: A Roadmap to the 351(k) Application Process — a $287 Value!

Key Benefits

LINKS TO KEY DOCUMENTS — Each issue provides you with links that support GEN's articles such as FDA guidances, warning letters, rules, full texts of proposed legislation and more.

FDANEWS DRUG DAILY BULLETIN — This daily email brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

ONLINE ACCESS — Consider our newsletter archive your personal library! Search your current issue — and hundreds of past issues — by keyword and relevancy.