Generics Bill Seeks Faster Access, Improved Safety

Pharmacy TimesJune 2012 Women's Health
Volume 78
Issue 6

A bill that would speed up approval of generic vaccines and biosimilar products has been forwarded to the House of Representatives floor, according to an article in the Pittsburgh Post Gazette.

The action follows a unanimous vote by the House’s Energy and Commerce Subcommittee held May 10, 2012. Sponsored by Representative Tim Murphy (R, PA), the bill is part of the FDA Reform Act, which includes the Prescription Drug User Fee Act, Generic Drug User Fee Act, and Medical Device User Fee Act. The acts either reauthorized several FDA programs relating to medical devices or created new programs to put generics on the market faster.

“When we set out on creating a generic drug program, we had one goal: to make cost effective, lifesaving medications more available and accessible,” Rep. Murphy said in a press release. “(This) legislation accomplishes that goal and levels the playing field for U.S. manufacturers by establishing one quality standard for all drugs sold in the United States.”

“The FDA Reform Act contains important metrics that will hold the FDA accountable for its performance, will help provide new therapies to our nation’s children, significantly improve scientific exchange at FDA’s advisory committees and ensure transparency and public input in the development of FDA’s guidance documents,” Fred Upton, chairperson for the Energy and Commerce Subcommittee, said in a release.

As part of the Generic Drug and Biosimilar User Fee Act, the generic drug industry would pay $1.5 billion over a 5-year period in exchange for faster reviews of generic drug applications, according to the House Energy and Commerce Committee’s bill fact sheet.

According to the Generic Pharmaceutical Association (GPhA), the additional funding allows the FDA’s Office of Generic Drugs to hire the additional personnel needed to approve generic drugs.

“With both the full House and Senate now set to consider these historic agreements, American consumers are one step closer to receiving faster access to low-cost, high-quality generic medicines,” Ralph G. Neas, president and chief executive of GPhA, said in a press release.

In addition, the bill would require the FDA to conduct more frequent inspections of foreign drug manufacturing plants, according to the Pittsburgh Post Gazette. Current regulations call for inspections at foreign plants once every 9 years. Domestic plants are inspected every other year, and the provision attempts to close that gap, according to Rep. Murphy’s website.

A portion of the $1.5 billion will be used for the generic manufacturer facility inspections, GPhA stated. The inspection measures, coupled with the expedited approvals, improve access to medications while also safeguarding quality. The programs were developed in conjunction with GPhA, the FDA, and other stakeholders.

The House of Representatives has not yet determined when the bill will be presented on the House floor.

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