McCain, Schumer Offer Bill to Speed Process of Generic Drug Approval

Sens. Charles Schumer (D-N.Y.) and John McCain (R-Ariz.) yesterday introduced a bill that "would make it harder for drug makers to hold on to brand-name patents" by closing loopholes in the Hatch-Waxman Act governing generic drugs, the AP/Baltimore Sun reports. The bill aims to "eliminate" the tactics brand-name drug manufacturers allegedly employ to delay generic production of patented drugs. By law, brand-name manufacturers are allowed to extend patents on their drugs, if they can prove they need extra time to market or research the drug. But consumer advocates say that many brand-name makers strike "exclusive deals" with generic manufacturers that delay or increase the cost of generic versions. The Federal Trade Commission is investigating such deals (AP/Baltimore Sun, 5/2). The McCain-Schumer bill, called the "Greater Access to Affordable Pharmaceuticals Act," would expand on provisions of the 1984 Hatch-Waxman drug patent law, which "has been seriously undermined by patent law loopholes that have allowed brand-name drug makers to use a host of tactics ... to delay the approval of lower-cost alternatives by several years," according to a McCain press release. With a goal of streamlining the generic drug approval process, the bill would:

• Eliminate the automatic 30-month stay the FDA grants brand-name makers who file suit against a generic maker's patent challenge;
  
• Allow the 180-day exclusivity period granted to the first generic applicant to become available to another generic applicant if the first applicant: reaches an agreement with the brand-name maker to stay out of the market, fails to go market within 90 days, fails to get FDA approval within 30 months, fails to challenge a new patent within 60 days, withdraws their application or is determined by HHS to have "engaged in anti-competitive activities";
  
• Incorporate FDA-recognized methods of establishing bioequivalence between brand-name and generic versions of a drug into the Hatch-Waxman law;
  
• Ask the FTC to study the bill's effectiveness within five years of its enactment (McCain release, 5/1).