McCain, Schumer unveil generic bill

Sens. Charles E. Schumer (D-NY) and John McCain (R-AZ) have introduced the Greater Access to Affordable Pharmaceuticals Act, bipartisan legislation to improve access to generic drugs.

"At a time when every attempt to lower the cost of prescription drugs gets bogged down in partisan wrangling, Senator McCain and I believe we have found a fresh approach that can break through the gridlock," said Schumer. "The broad coalition supporting this bill is a testament to the way it achieves monumental savings for seniors and families not by redrawing ideological battle lines, but by simply restoring the intent of our patent laws."

Bill highlights

Under the proposed legislation:

•Â The automatic 30-month stay granted by the Food and Drug Administration to brand-name drug makers who file suit against generic manufacturers' patent challenges would be eliminated. Instead, brand-name manufacturers would seek a preliminary injunction from the courts. In an effort to clarify and expedite certification, brand-name manufacturers would be required to list all of a drug's relevant patents and certify with the FDA that the list is complete and accurate.

•Â Generic drug makers would be able to seek a declaratory judgement on any patent listed in the Orange Book, the FDA's catalog of currently held patents, just as brand-name manufacturers have standing to sue on any patent challenge.

•Â The 180-day exclusivity period granted to the first generic applicant would become available to the next-filed applicant if the first applicant reached a financial settlement with the brand name to stay out of the market until the patents had expired; failed to go to market within 90 days once their application was effective; did not get FDA approval within 30 months; failed to challenge a new patent within 60 days; withdrew their application; or was determined by the Health and Human Services Secretary to have engaged in anti-competitive activities.

•Â Individuals or groups filing citizen petitions would be required to certify that their petitions were factually-based, were warranted by existing laws or regulations, and were not submitted for any anti-competitive purposes, such as to cause unnecessary delay. Any petitions believed to be used for anti-competitive purposes would be investigated by the Federal Trade Commission, and any company making false statements would be subject to existing criminal penalties.

•Â The multiple methods of establishing bioequivalence that are currently recognized by FDA regulations would be incorporated into statute, reducing frivolous legal challenges and accelerating consumer access to those drugs that require alternative forms of testing.

•Â The FTC would study the bill's effectiveness within five years of its enactment to see if it had increased consumer access by promoting competition and enabled generics to come to market in a fair and expeditious matter consistent with the intellectual property rights of patent holders.

Said McCain: "The GAAP bill will provide Americans with choices when buying their medicine by ensuring that all safe and effective pharmaceuticals are made available to them in a timely manner and not kept off the market for frivolous or financially profitable reasons." PR