The US House of Representatives has approved legislation to allow consumers, pharmacists and wholesalers to import prescription drugs from Canada and elsewhere, but President Bush is expected to veto it on the grounds of cost.
The measure, which was passed in a 237-18 vote, forms part of a $91 billion agriculture appropriations bill which also includes farm subsidies and food-stamp programmes and is the final domestic spending bill to be approved by the House for the financial year starting October 1. An attempt to remove a provision from the measure which would prohibit the US Food and Drug Administration from using federal funds to enforce a ban on imports was rejected in a 283-146 vote.
The White House is strongly opposed to prescription drug imports, but it is the measure’s cost, and not its content, which is expected to spur a presidential veto of the measure.
Also, Representative John Dingell, chairman of the House Energy and Commerce Committee, has introduced legislation aimed at strengthening the safety of imported food and drugs. His bill would create a user fee on imported food and drug shipments to generate funds which would be used to hire extra staff at the US border and FDA to test import samples and research new testing techniques. “Tainted imports have slipped into our country undetected and the resulting problems will continue to grow if we don’t take steps to tighten safety measures,” said Rep Dingell, a Democrat.
PDUFA reauthorisation “next month,” FDA tells staff
Meantime, as concerns grow that Congress will likely fail to finalise the FDA Revitalization Act before the August recess, Commissioner Andrew von Eschenbach has written to agency staff stressing his belief that the legislation will be passed when legislators return in September. In an e-mail to staff reported by FDA Legislative Watch, Dr von Eschenbach says he remains confident that the Prescription Drug User Fee Act (PDUFA) and its companion bill covering medical devices will be reauthorised next month, and also tells staff that the agency will use “carry-over” funding to avoid sending out Reductions In Force (RIFs or lay-offs) to staff whose salaries are supported by drug user fees.
Senator Mike Enzi, Republican Ranking Member of the Senate Health, Education, Labor and Pensions (HELP) Committee, has also expressed his frustration with the slow progress of the Act, in a letter to Senate leaders urging them to move forward on S 1082, the Senate version on the Act.
If the user fee programmes are not renewed before Congress goes into recess, the FDA will have no choice but to send RIFs to hundreds of its staff, Sen Enzi’s letter warns Senate Majority Leader Harry Reid and Minority Leader Mitch McConnell. “These highly-skilled and dedicated public servants are not likely to wait until Congress musters enough interest to act to maintain the user fee programs - they will find other jobs,” he writes, adding: “A staff exodus would be a disaster for this agency, and for the public health it safeguards so zealously.” By Lynne Taylor