A Senate panel approved a bill with significant user-fee, DTC moratorium and drug-safety provisions.
The bill, sponsored by Sens. Edward Kennedy (D-MA) and Michael Enzi (R-WY), passed in the Senate Health Education, Labor and Pensions Committee by a 15 to 5 vote, setting the stage for a floor vote in June. Kennedy and Enzi are the chairman and ranking Republican member of the committee, respectively. The bill includes some of the following provisions, according to Dow Jones and Reuters reports:
* Renews the user-fee legislation, which expired last September, until 2012 while upping the amount of fees the agency can collect from pharmaceutical companies. It adds $50 million to a deal reached by the FDA to collect $393 million from drug firms. Another agreement, one the FDA reached with the medical device industry to collect about $287 million in fees over the next five years, also was placed in the bill.
* Bans DTC advertising of a new drug for two years. The bill also authorizes more money and gives the FDA more power to review TV drug ads before they are aired. Many companies already submit such ads to the agency voluntarily prior to airing. According to Reuters, Republicans tried to strike the ban on constitutional grounds and because, they argued, the deal to have companies pay fees for review of TV commercials made a blackout period unnecessary.
* Requires FDA to monitor new drugs, as well as older drugs approved for alternate uses, at 18 months and three years after approval. The bill also gives FDA more power to require pharma companies to conduct post-marketing surveillance studies and to alter warnings on labels.
* Mandates companies to register clinical trials in a public database and make results accessible.
The Kennedy-Enzi bill is one of several on the table during hearings on the reauthorization of the Prescription Drug User Fee Act (PDUFA), which sets the user fees manufacturers pay to speed the review of new drugs. The House of Representatives has yet to act on a companion measure.
The White House objected to several of the provisions in the Kennedy-Enzi bill, saying risk management strategies are not needed for every drug and that applying them this broadly could slow down drug approval.
Meanwhile, the Senate blocked a bill that would have allowed the US government to negotiate on Medicare drug prices.
Under the Medicare drug benefit, which provides prescription drug coverage for seniors and the disabled, the government is prohibited from negotiating prices with drug companies. Some lawmakers, mostly Democrats, have called for lifting that ban, arguing that the government could use its buying power to negotiate lower costs than can individual insurers, which are permitted to negotiate under the current scheme.
But Democrats couldn’t muster the 60 votes needed to bring the bill up for a vote, according to the Associated Press.
Republicans argued that the program is within budget because the private sector, not the secretary of Health and Human Services, has the power to hold negotiations. They successfully blocked a motion to move ahead to the bill, with the voting 55-42--five short of the votes needed to proceed.
Democratic lawmakers argued that their goal wasn’t to take over the role of private health plans, but rather to allow the health secretary to intervene for certain expensive drugs that have no substitute, such as some of the drugs taken by cancer patients, notes the AP.