Generic Drug Act Awaits Final Approval

Both houses of Congress recently approved changes to the FDA Safety and Innovation Act, which would allow generic drugs to enter the market more quickly. The bill is now awaiting action from President Obama.

The legislation addresses several consequences of the Medicare Modernization Act of 2003, particularly the 30-month exclusivity forfeiture provisions, according to the Generic Pharmaceuticals Association (GPhA). The bill also includes important measures pertaining to supply chain security.

“GPhA fully supports the Food and Drug Administration Safety and Innovation Act and applauds both the House and Senate for the remarkable effort and bipartisan cooperation they have shown throughout this process,” said Ralph G. Neas, president and chief executive officer of GPhA.

“The historic user-fee legislation—the most important pharmaceutical legislation since the 1984 Hatch—Waxman Act—will provide FDA with additional resources and ensure all participants in the US generic drug system, whether US-based or foreign, comply with our country’s strict quality standards. Very importantly, the programs will make certain that all Americans receive timely access to safe, effective, and affordable generic drugs. We now urge President Obama to quickly sign the user fee legislation into law so that consumers, the FDA, and generic manufacturers can begin to see its many benefits.”

The bill, which was introduced in May 2012, includes provisions pertaining to generic vaccines and biosimilar products, as well as generic prescription medications. In addition, it reauthorizes several existing regulations relating to medical devices and creates new programs that bring generics to the market faster.

The act includes a provision wherein generic drug manufacturers would pay $299 million in annual user fees over a 5-year period in addition to the funding Congress allots to the FDA each year. According to the GPhA, these annual fees would be used to hire additional FDA personnel for approving generics. If the president signs the act, the program will begin October 1, 2012.

A portion of the bill’s funding would be used for inspections of foreign generic manufacturing plants, which would occur more frequently than the current 9-year inspection schedule.

According to sponsor Tim Murphy (R-PA), the bill aims to save consumers up to $100 billion annually through faster approval of generic medications.

“Real reform of the nation’s broken healthcare system begins with promoting quality and affordability. Life-saving drugs are only useful if you can afford them, and with this critical legislation the FDA will finally have a system in place to bring more generics to the market place and inspect all overseas factories,” Rep. Murphy said.