Make Cheaper Generic Biotech Drugs Available Sooner, FTC Urges

Making less-expensive generic versions of costly brand-name biotechnology drugs available to consumers sooner would save the U.S. healthcare system billions of dollars a year, give cash-strapped patients more treatment options, and promote technological innovation among drug makers, the Federal Trade Commission said today.

Biologics, as the drugs are called, are among the most expensive and complicated on the market. They tend to be injectable and derived from living cells to treat a variety of diseases, from cancer to arthritis and other autoimmune system disorders.

Drug companies like Genentech Inc. and Amgen Inc that invest millions of dollars in the research and development of biologics want U.S. lawmakers considering how to overhaul the nation’s crippled healthcare system to grant then 12 to 14 years of protection before their products must face generic competition. The companies have said opening their products to cheaper competition too soon would discourage development of the costly therapies. Indeed, many generic drug companies are eagerly chomping at the bit to enter the biologics drug market as soon as the government will let them in.

An FTC report released today calls the 12 to 14-year exclusivity period the companies want “too long to promote innovation.” By providing exclusive use of drug formulas to brand-name developers for so long, there is little incentive to improve or come up with new ways to provide the same treatments for less cost, the FTC said.

The issue of how long to grant regulatory exclusivity to the makers of biologics figures to be a major point of contention in the upcoming Congressional healthcare hearings.

The FTC report also indicated that brand-name drug makers may be crying wolf by complaining about unfair competition from generic drug makers, since trade regulators suspect that competitors would only produce generic version of top-selling drugs that rack up $250 million or more in annual sales. That would leave the bulk of brand-name biotechnology drugs unchallenged by less-expensive generics, the FTC said.

Clearing the way for the Food and Drug Administration to approve generic copies of brand-name drugs sooner “would be an efficient way to bring these lower-priced drugs to market,” the FTC report said.

Biologics are usually injectable drugs and tend to be more expensive and complicated than traditional chemical medicines because they are made from living cells. They are used to treat everything from cancer to autoimmune diseases such as arthritis.

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