Renewal of Pediatric Exclusivity Provision Has Broad Support
Lawmakers, pediatricians and FDA and pharmaceutical representatives yesterday expressed "overwhelming" support for reauthorization of the 1997 FDA Modernization Act's "pediatric exclusivity provision," which allows drug companies to receive a six-month patent extension if they conduct clinical research on a drug's effectiveness on children, CongressDaily reports. Speaking at a meeting of the Senate Health, Education, Labor and Pensions Committee, Sen. Christopher Dodd (D-Conn.), one of the original sponsors of the law, said that more than 300 pediatric drug studies have been initiated since the law was passed in 1997, compared to 11 conducted in the six years prior (Rovner, CongressDaily, 5/8). Janet Woodcock, the FDA's research director added, "From the inception of this program, the industry has responded enthusiastically to the incentives offered in the pediatric exclusivity provision. FDA continues to believe that this program holds the promise of significantly expanding children's access to and safe use of important therapeutics." An aide to Sen. James Jeffords (R-Vt.), chair of the committee, said that he would seek a five-year extension of the exclusivity provision before it expires at the end of this year.
A few "discordant notes" did emerge during the hearing, with some questioning whether drug companies have unduly benefited from the provision. Noting that manufacturers of "top-selling drugs" can reap "windfall profits of as much as $1 billion" because of the provision, Sen. Hillary Clinton (D-N.Y.), asked the committee to consider placing a cap on the amount of money a drug company could make through the patent extension (MacDonald, Hartford Courant, 5/9). Drug industry representatives, however, said that most of the drugs being tested have not been "blockbuster[s]" (CongressDaily, 5/8). Janet Heinreich, the General Accounting Office's director of health research, said that 53.5% of the drugs for which the FDA requested pediatric testing had sales of less than $120 million in 1999, while only 7.7% had sales totaling more than $1 billion. Heinreich added that drug companies spent an average of $3.87 million on each study (Hartford Courant, 5/9).
In an attempt to address "the shortcomings of the original law," Dodd and Sen. Mike DeWine (R-Ohio) on Monday introduced the "Best Pharmaceuticals for Children Act" (S 838), which would encourage pediatric testing of drugs whose patents have expired, CongressDaily reports. The bill would establish a government fund, starting at $200 million, for grants to test "off-patent" drugs. The bill would also "shorten the period it takes for new labels to be added to drugs reflecting the results of pediatric testing." According to the FDA, only 18 of the 28 drugs granted a patent extension "have had their labels changed" (CongressDaily, 5/8).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.