Senate measure would allow generic versions of biotechnology drugs after five years

Sens. Charles Schumer (D-N.Y.) and Susan Collins (R-Maine) on Thursday introduced legislation (S 726) that would allow FDA to approve generic versions of biotechnology drugs after a five-year period of brand-name patent exclusivity, the New York Times reports.

President Obama has emphasized the need for generic competition in the biotech industry and has estimated that it could save $9.2 billion over 10 years, which could be used to finance his health care reform plan. A similar bill passed by the Senate Health, Education, Labor and Pensions Committee last year would have given biotech products 12 years of exclusivity, but it died without being voted on by the full Senate.

The bill would allow FDA to determine on a case-by-case basis whether generic biotech drugs require additional testing before they can be marketed. It also would grant an additional three years of exclusivity if modifications are made to a biotech product. A similar House bill (HR 1427) was introduced two weeks ago by House Energy and Commerce Committee Chair Henry Waxman (D-Calif.) (Harris, New York Times, 3/27).

Schumer said, "It's past time we created a way for generic versions of these expensive drugs to come to market," adding, "We have a bipartisan plan that we know consumers will support and we believe the president will, too" (Perrone, AP/Miami Herald, 3/26). AARP Vice President Nancy LeaMond said, "The crushing cost of biologic drugs is leaving far too many Americans without access to life-saving treatments for devastating illnesses like multiple sclerosis and cancer" (New York Times, 3/27).

The AP/Herald reports that Senate HELP Committee Chair Edward Kennedy (D-Mass.) is the lawmaker "best positioned to hammer out an agreement"' on exclusivity. A Kennedy aide on Thursday said the senator would not endorse the five-year window and instead would seek a 12-year exclusivity period (AP/Miami Herald, 3/26).

Industry Reaction

Biotech firms have criticized the legislation, saying it could result in the sale of unsafe medicines, fewer cures for diseases and fewer jobs in the industry, the Times reports. Jeff Joseph, a spokesperson for the Biotechnology Industry Organization, said, "It's a shortcut that would jeopardize patient safety and undermine our ability to develop future cures and therapies." Genzyme CEO Henri Termeer said, "For a tiny little bit of savings, we are giving up the potential to come up with treatments for Parkinson's and Alzheimer's, and it's just not very sensible" (New York Times, 3/27).

Pharmaceutical Research and Manufacturers of America in a statement said, "Developing biologic cures is a complex and difficult undertaking," and such an exclusivity period would not allow firms to recoup the investments required to develop these products. It added, "Congress needs to approach any changes in this arena carefully" (AP/Miami Herald, 3/26).