By Lisa Seachrist
WASHINGTON ¿ The Pharmaceutical Research and Manufacturers of America (PhRMA) joined the FDA as co-defendants in a suit filed by the generic drug industry to halt the implementation of the Pediatric Drug Testing provision of the FDA Modernization Act of 1997 (FDAMA).
The lawsuit, filed Feb. 19 in U.S. District Court, challenges the agency¿s efforts to implement the law, claiming the provision is being applied too broadly and without consultation with experts in pediatric pharmacology.
By becoming a defendant in the case with the FDA, PhRMA hopes to challenge these assertions. The American Academy of Pediatrics is also hoping to intervene on the behalf of the agency in this litigation.
¿We entered this suit as a co-defendant because we feel that strongly about this issue,¿ said Jeff Trewhitt, media spokesman for PhRMA. ¿This provision in the law represents the clear intention of Congress, and the victims in this lawsuit are going to be pediatric patients.¿
As passed, FDAMA requests that drug companies conduct pediatric studies for new drugs and drugs already on the market, in return for an additional six months of market exclusivity. In effect, it gives brand-name drug companies six more months without generic competition if they provide data that allow pediatricians to prescribe the medications safely for children.
The provision was added to FDAMA because less than 25 percent of the drugs that are prescribed for children have been tested in children. Depending upon age, children metabolize drugs differently from adults. Without adequate prescribing information for children, physicians are often left guessing what an effective dose of a medication would be.
¿This is an honorable quid pro quo for doing the studies to get this information,¿ Trewhitt said.
The FDA and the generic industry have agreed to allow PhRMA to intervene in the case. However, only the FDA has agreed to allow the American Academy of Pediatrics (AAP) to intervene. The judge in the case will determine sometime this week whether the academy may serve as a participant in the proceedings.
¿The academy wants to be a full participant with FDA in this suit,¿ said Stephan Lawton, an attorney representing the organization and a partner in the Washington-based law firm of Hogan & Hartson. ¿We believe their input is important as the only true experts in this field.¿
At a news conference Friday, the academy took issue with the generic industry¿s claims.
¿The provision has been implemented quite broadly at the urging of the academy,¿ said Lawton. ¿The statute also requires that there be consultation with the pediatric community. The generics industry incorrectly says that there was no consultation.¿
FDA Has Approved 44 Pediatric Protocols
To date, the brand-name pharmaceutical industry has made almost 100 requests to study drugs in pediatric populations, and the agency has approved 44 protocols.
Philip Walson, a member of AAP¿s committee on drugs and a professor of pediatrics at Ohio State University, in Columbus, took particular umbrage at the idea that there had been no consultation with appropriate experts, noting that all 25 pediatric pharmacologists in the country, as well as other experts, had been contacted when the agency was attempting to create its list of drugs.
¿We feel that we didn¿t get enough drugs on the list,¿ Walson said. ¿This act has worked. We now have 44 drugs being tested in this year for pediatric indications, and that¿s more than we¿ve had in any other three- to five-year period.¿
Lawton pointed out there is a five-year sunset clause on the provision for Congress to reevaluate the program, and delaying the implementation of the law will eat into those five years. He said that tactic of the generic industry appeared to be ¿delay, delay and delay.¿
¿We have to find a way to get the generic industry on board to help kids,¿ said Walson. ¿I don¿t see how this suit does that.¿ n