Content about Prescription Drug User Fee Act

It's been long accepted that politics makes strange bedfellows. That's certainly the case with the reauthorization in 2012 of the Prescription Drug User Fee Act.

Leaders in both the branded and generic drug industries praised the reauthorization last June of PDUFA, the 20-year-old system by which research-based pharmaceutical companies help fund the government's expensive review and testing process for new drug applications.

NEW YORK — One of the Food and Drug Administration's chief duties is ensuring the quality of food and drug products, and that was the focus of a keynote address delivered Friday morning by FDA commissioner Margaret Hamburg at the Generic Pharmaceutical Association's annual meeting.

In the address, viewed via webcast, Hamburg addressed issues ranging from quality to drug shortages to follow-on biologics, praising the generics industry's role in contributing more than $1 trillion in savings to the healthcare system over the past decade.

NORTHBROOK, Ill. — Astellas Pharma US announced the Food and Drug Administration's review of their new drug application for tacrolimus extended-release capsules, a once-daily formulation of the calcineurin-inhibitor immunosuppressant tacrolimus, for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients.

NEW YORK — The generic drug user fee program may have hit a speed bump due to budget problems in Congress, according to published reports.

Bloomberg reported that implementation of the law may be delayed because Congress must first pass legislation authorizing the Food and Drug Administration to collect money from generic drug companies, but the problem is that members of Congress will leave Washington this week, not to return until after the Nov. 6 elections.

SILVER SPRING, Md. — The Food and Drug Administration has released draft guidance for the Generic Drug User Fee Amendments to the Prescription Drug User Fee Act, the agency said.

A collection of documents posted on the FDA's website includes guidance for the generic drug industry on self-identification of generic drug facilities, sites and organizations, questions and answers about the draft guidance and others.

NEW YORK — While most of the attention to the Prescription Drug User Fee Act reauthorization focused on what it would mean for the generic drug industry, one other aspect of the law recently drew applause from a group that advocates on behalf of the blind.

MOUNTAIN VIEW, Calif. — A drug maker has resubmitted its new drug application to the Food and Drug Administration for an acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

Alexza Pharmaceuticals said it received a complete response letter for Adasuve last month from the regulatory agency. The CRL outlined the FDA's concerns about Alexza's manufacturing facility and the drug's draft product labeling. Alexza said it believes it has addressed these concerns in its resubmitted application.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores on Wednesday urged Congress to pass the Prescription Drug User Fee Act, legislation essential to the review process for new medications and that also contains important pro-patient, pro-pharmacy provisions.

The U.S. House and Senate passed their versions of PDUFA last month and worked to reconcile their individual bills into one final bill. Both chambers are expected to vote on the final conference report this week.

With overwhelming support in both the U.S. House and Senate and the strong backing of President Obama, a reauthorization of the landmark Prescription Drug User Fee Act that funds new drug application reviews at the Food and Drug Administration is a near certainty, probably within days or weeks at most. But one amendment to the Senate's version of PDUFA reauthorization, contained in the Food and Drug Administration Safety Innovation Act, could threaten both retail pharmacies and the patients they serve.

WASHINGTON — The House of Representatives on Wednesday passed legislation that reauthorizes the Food and Drug Administration’s prescription drug user fee programs that are scheduled to expire in September. H.R. 5651 passed the House by a vote of 387 to 5.

The bill, a version of which already passed through the Senate, now heads to committee where the House and Senate versions of the bill can be reconciled before Oct. 1 and submitted to the president. According to published reports, the Senate version would require more scrutiny for some new devices.

NEW YORK — Federal and industry officials have been negotiating a federal track-and-trace system as part of a reauthorization of the Prescription Drug User Fee Act, according to published reports.