Washington, D.C. – Citizens Against Government Waste (CAGW) released today its report Biogenerics: What They Are, Why They Are Important, and Their Economic Value to Taxpayers and Consumers.  The report estimates that if the Food and Drug Administration (FDA) was provided with the appropriate statutory framework to approve generic forms of biotech drugs for the marketplace, these drugs could save taxpayers and consumers $43.2 billion between 2011 and 2020.

“Biogenerics hold great promise for taxpayers and consumers,” stated Tom Schatz, president of CAGW.  “Biotech therapies have improved the lives of millions of Americans.  Unfortunately, they can be very expensive.  Some can even cost an individual $10,000 per year.  But a thriving biogeneric industry would encourage competition, bring down prices, and stimulate more research.”

Many biotech drugs are losing, or have lost, their patent protection, but most biotech drugs are regulated differently by the FDA than chemically-based drugs.  Therefore, a generic drug company could not follow the abbreviated approval process under the Hatch-Waxman Act to produce a biogeneric drug.

“The FDA believes they need a statutory framework to allow them to approve a biogeneric for the marketplace.  Legislation has been introduced that would create such a pathway and it should be considered by Congress,” remarked Schatz.

CAGW has long supported a vibrant generic drug market and has resisted attempts by brand name companies to use the government to create roadblocks and interfere with the marketplace in order to restrict patients’ access to generic drugs.

“Regrettably, the biotech industry is putting up a fight to stop an abbreviated approval process from being developed.  Some members of Congress are actively looking to force price controls on both the biotech and pharmaceutical industries to obtain lower prices.  This would not get less expensive therapies in the marketplace, and it would destroy our nation’s vital pharmaceutical industry, just as price controls have done in Europe.  The best approach is the creation of an accelerated pathway to bring biogenerics to the market that protects patients while balancing the financial needs of brand name and generic drug companies, just as Hatch-Waxman has done,” concluded Schatz.

Citizens Against Government Waste is a nonpartisan, nonprofit organization dedicated to eliminating waste, fraud, mismanagement and abuse in government.