House Approves Final Pediatric Exclusivity Measure, Extending Extra Patents for Drugs Tested on Children

The House on Dec. 18 approved the reauthorization of a 1997 law granting pharmaceutical companies an extra six months of patent protections if they test a drug's efficacy on children, sending the bill to the president's desk, the Hartford Courant reports (Hartford Courant, 12/19). The measure, which was approved by the Senate last week, would extend by six years the pediatric exclusivity law, which supporters say has led to some 400 drugs being tested on children since its enactment. The reauthorization would expand the original law by encouraging testing of drugs whose patents have expired (CongressDaily/AM, 12/19). Before the exclusivity law, pediatric testing "rarely took place," the Courant reports. Sen. Christopher Dodd (D-Conn.), co-sponsor of the Senate's version of the extension, said, "Guessing may work for cooking, but when it comes to dosages of medicines for children, it's a recipe for disaster. This measure helps remove any guesswork," he said, adding that President Bush is expected to sign the extension. Some consumer groups opposed the reauthorization, saying that pediatric exclusivity has primarily served to boost drug company revenues through the additional patent protection (Hartford Courant, 12/19).

Bristol Loses Glucophage Campaign
As expected, the final version of the reauthorization did not include language granting Bristol-Myers Squibb a three-year patent extension on its diabetes drug Glucophage. The company, which conducted pediatric tests on the drug, had launched a major lobbying effort to convince lawmakers that generic versions of its drug should not be allowed to enter the market because a 1984 law gives drug makers an extra three years of patent protection if they discover a new use for a medication. "Once again, a bipartisan coalition has turned back an effort by a large pharmaceutical company to gouge consumers," Sen. Richard Durbin (D-Ill.) said, adding, "The Glucophage loophole would have cost patients and their families more than $2 million per day" (Washington Post, 12/19).