The US Bush administration will veto legislation to reauthorise the Prescription Drug User Fee Act (PDUFA), which is currently being debated in the Senate, if it includes an amendment to allow prescription drug reimportation, as such a move would lead to unapproved, unsafe and counterfeit drugs being brought into the USA, a White House Statement of Administration Policy has warned.
If such an amendment were to be included in the final version of the legislation - the Food and Drug Administration Revitalization Act (S 1082) - “the President’s senior advisors would recommend that he veto the bill,” the White House Office of Management and Budget (OMB) stated.
Two Senators, Democrat Byron Dorgan and Republican Olympia Snowe, have proposed attaching such an amendment to S 1082, in the form of the the Pharmaceutical Market Access and Drug Safety Act of 2007 (S 242), which they introduced into the Senate in January. Senators who oppose reimportation include Republican Senator Mike Enzi, the ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee, and who is S 1082’s co-sponsor with HELP panel chairman, Democrat Edward Kennedy.
The President also opposes moves to establish a pathway at the FDA for the routine approval of generic versions of biotechnology drugs, the White House added; there has to be “robust scientific, regulatory and legal discussion” before any such legislation is approved, spokesmen stressed.
Senators urged to reject DTC advertising ban
Meantime, drug manufacturers, broadcasters and advertisers have joined together to press Senators to reject S 1082’s proposal to ban direct-to-consumer (DTC) advertising of new drugs to the public for two years.
The Pharmaceutical Research and Manufacturers of America (PhRMA) said that DTC empowers patients, and such a restriction would prohibit educational information from getting into the hands of patients who need it most. Banning this information, even for just a couple of years, “is not in the best interest of patients and physicians who, every day, make important health care decisions,” warned the group.
Moreover, especially for people living with HIV/AIDS, a statutory two-year silence on advertising new drug options makes no sense at all, added Sue O’Connell, president of the National Gay Newspaper Guild. “Worse, it is likely to betray a patient’s knowledge and ability to speak to their physician about new therapies as they emerge. Speeding up the cycle of newer drugs, and advertising their efficacy, is a key part of patient and physician education,” she said.
However, the Senate debate has heard strong attacks on the prescription drug industry, with Independent Bernie Sanders calling the sector “the most powerful, the greediest special interest” in the USA. The industry’s 1,200 registered lobbyists “descend like locusts into the offices of members of Congress” and urge them to “make sure that American people continue to pay the highest prices of medicine in the entire world,” Sen Sanders told legislators. By Lynne Taylor
– The Congressional Budget Office has estimated that implementation of S 1082 would cost $547 million during the period 2008 to 2012. However, in a cost estimate on the bill issued just before the Senate began debating the bill, the CBO notes that: “because most of the cost of FDA activities would be offset by user fees, the largest component of the net discretionary cost of implementing S 1082 would be an estimated $432 million in spending over the 2008-2012 period for pediatric research conducted by the National Institutes of Health.”