Saturday, January 16, 2010 May Get Less Protection

President Obama is pushing for a last-minute change in the final health care bill that would shorten the time that expensive biotechnology drugs would be shielded from generic competition, pharmaceutical industry officials said Thursday.

Any White House intervention would be welcome news to generic pharmaceutical companies, as well as to some consumer groups, insurers and big employers, which have complained that the proposed House and Senate bills would not allow for robust competition.

But it could throw another wrench into negotiations. At a time when Congressional leaders are trying to resolve differences in the House and Senate bills, the issue of biotech drugs is one aspect on which both bills agree.

Both the House and Senate bills would for the first time create rules by which so-called biologic drugs, which are made in living cells, would be subject to copycat competition, saving the health care system billions of dollars over 10 years.

The drugs, which include big sellers like the cancer drug Avastin and the arthritis drug Enbrel, can cost tens of thousands of dollars a year. Biologics are not governed by the Hatch-Waxman Act, which covers generic competition for more conventional drugs made from chemicals, like Prozac or Lipitor. After the patent on a biologic drug expires, competitors may produce similar products, but they are treated by the health care system as if they were entirely new drugs, not substitutes like generics.


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