New Legislation Would Introduce Generic Biotech Drugs Faster
Bipartisan legislation introduced today in the U.S. Senate would make cheaper, generic versions of brand-name biotech drugs available faster than makers of biotech drugs want to face generic competition.
The bill, proposed by Sen. Charles Schumer (D-N.Y.) and Sen. Susan Collins (R-Maine), would require makers of biotech drugs, which are derived from living cells, to compete with lower-cost generic versions after just five years on the market.
Biotech drugs do not currently face generic competition, but companies that make them, including Amgen Idec. and Genentech, have argued for at least 14 years of exclusivity before facing generic competition if the current rules against generics are changed.
The proposed Senate bill is considered a blow to the makers of biotech drugs. President Barack Obama also has made increasing access to lower-cost generic drugs a cornerstone of his plans to dramatically overhaul the nation’s healthcare system.
“It’s past time we created a way for generic versions of these expensive drugs to come to market,” Schumer said in introducing the new bill. “We have a bipartisan plan that we know consumers will support and we believe the president will too.”
Biotech Drugs Under Fire
The blockbuster cancer drug Avastin and other biotech drugs can cost thousands of dollars a month and collectively, the high-tech medications cost the United States health care system more than $40 billion each year.
The Food and Drug Administration does not currently have the power to review or approve generic copies of biotech drugs. When the law was changed in 1984 to allow the FDA to approve generic copies of chemical drugs, biotech drugs were not included, because the biotech industry argued that their drugs were too complex to be duplicated by generic competitors.
Also, the high cost and time involved in developing, researching, and manufacturing biotech drugs meant exposing them to cheaper generic versions too soon would unfairly punish biotech drug makers, the industry said.
Other, Similar Legislation Already Introduced
Rep. Henry Waxman (D-Calif.) recently introduced a similar Congressional bill aimed at bringing generic version of costly biotech drugs to market sooner.
Waxman’s bill, like the new Schumer-Collins legislation, would empower the FDA to decide whether a drug company must test its generic biotech drug on patients before launching it. Generic companies have opposed that proposed rule and said that requiring clinical testing of generics could increase the costs of making generics to nearly as high as the brand-name originals.
Generic Biotech Competition Has Its Opponents
Sen. Ted Kennedy (D-Mass.), chairman of the Congressional committee that oversees the FDA, appears to be in the best position of any lawmaker to succeed in creating a bill to approve the use of generic biotech drugs.
However, Kennedy is said to favor plans which would give biotech drug makers 12 years of exclusivity before facing generic competition.
The Pharmaceutical Research and Manufacturers of America says implementing a shorter exclusivity period on biotech drugs could discourage companies from investing in drug development and require layoffs in the pharmaceutical industry.
U.S. biotech drug industry supporters also point to the European Union, which has approved generic biotech drugs since 2006 with 11 years of exclusivity for original products.
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