House panel supports 12-year exclusivity for biotech drugs Print E-mail
By Jude Santos & Wire Reports   
Monday, 03 August 2009 11:16
A U.S. House committee, voting 47-11, approved an amendment that would give brand-name makers of biologic drugs 12 years of exclusivity, dealing a setback to efforts by President Barack Obama and consumer groups to open the market to generic drug makers sooner. The House Energy and Commerce Committee added the amendment to the broader health-care legislation making its way through Congress. The measure would also allow "evergreening," the practice by pharmaceutical companies of making minimal adjustments to their drugs, such as creating extended-release versions, as a way to lengthen their monopoly.

Mr. Obama and some Democrats, including the energy committee chairman, Rep. Henry Waxman, D-Calif., have pushed for getting generic versions of complex biologic drugs to the market in five to seven years, saying it would speed up access for consumers to cheaper generic brands and help reduce the country's health-care costs.

The longer sales monopoly was supported by brand-name pharmaceutical companies, as well as many fiscally conservative Democrats, who have been demanding more cost savings in the $1 trillion health-care bill. More on this story in a report in this weekend's Wall Street Journal.

A U.S. House of Representatives committee voted on Friday to ban deals in which drug companies pay generic firms to delay bringing out a cheaper, copycat version of a drug.

The House Energy and Commerce Committee, by a voice vote, approved a bill to prohibit branded drug companies from compensating generic drug firms to delay entry.

Rep. Bobby Rush, the Illinois Democrat who introduced the amendment, said it would curb "these eyebrow raising settlements."

The FTC, which says the deals cost Americans $3.5 billion per year, has challenged them in court but with mixed success.

The first known "pay for delay" was in 1994 when Bristol-Myers Squibb Co paid $290 million to Schein Pharmaceutical to delay the sale of a generic version of Bristol's anxiety drug Buspar.

In Brussels, EU Competition Commissioner Neelie Kroes said this month that she was determined to oppose such settlements, which she said had pushed up European consumers' bills by 20 percent between 2000 and 2007.

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