Lance seeks protection for FDA access to user fees

Rep. Leonard Lance (R-N.J.) recently introduced a bill that would exempt approximately $1 billion in annual fees paid by drug and device companies to review new products.

Lance, a member of the Energy and Commerce Subcommittee on Health, said the proposed legislation is important because it would protect the Food and Drug Administration’s access to industry user fees. The government sequestration is preventing the FDA from accessing the industry-paid user fees during the current fiscal year.

“These user fees cannot, by law, be used for any other purpose and their sequestration does not decrease the nation’s deficit,” a press release distributed by PhRMA said. “Preventing FDA from fully accessing these user fees only serves to exacerbate the severe budgetary constraints of a historically underfunded agency, to the detriment of patients and public health.”

The user-fee program was created for the approval of drugs and medical devices and account for approximately 35 percent of the FDA’s budget.

“The FDA user fee program is critical in ensuring timely patient access to life-saving medicines and medical devices,” Lance said. “Protecting this program from the congressional sequester will allow the FDA to fulfill its critical public health mission.”

Reps. Anna Eshoo (D-Calif.), Doris Matsui (D-Calif.) and Mike Rodgers (R-Mich.) are all cosponsors of the proposed legislation, dubbed the FDA Safety Over Sequestration Act. Sens. Roy Blunt (R-Mo.), Daniel Coats (R-Ind.), Al Franken (D-Minn.) and Jerry Moran (R-Kan.) recently introduced companion legislation in the Senate.