Lawmakers are pushing forward with legislation that could help create generic competition for Big Biotech, drastically lowering the costs of expensive biotech drugs and changing the landscape in the pharmaceutical industry forever.
The Senate is expected to vote Wednesday on a bill that would extend the 15-year-old process of requiring drug companies to pay fees to the Food and Drug Administration to help fund the drug review process. Advocates say the law has helped streamline the review process so that it takes months instead of years to get life-saving drugs approved for the market.
On the same day the Senate is voting, members of the House Energy and Commerce Committee are holding a hearing on a bill that would create a way for the FDA to review generic biotech drugs. Right now, there's nothing on generic biotech drugs in the Senate bill, and there's no guarantee that the bill will be modified.
Rep. Henry Waxman of California introduced a "biogenerics" bill in February along with Reps. Jo Ann Emerson of Missouri and Frank Pallone of New Jersey, as well Senators Hillary Clinton and Charles Schumer from New York.
The biogenerics bill would create a system for the FDA to review generic versions of biotech drugs, a $40 billion business in the United States last year, according to IMS Health, a drug industry research firm.
The bill has not yet been voted on in the House. Some believe that the best way to get the bill passed is for it to be folded into the FDA "reauthorization" bill, which has a much better chance of passing.
More
No comments:
Post a Comment