US House Passes Medical R&D Funding Bill

By a vote of 392 to 26, the US House of Representatives has overwhelmingly passed the 21st Century Cures Act, a nearly 1,000-page piece of legislation aimed at accelerating federal approval of drugs and medical devices as well as boosting biomedical research. It would additionally increase funding for cancer research and help battle addiction to prescription drugs. Reports from the US capital said the upper house of the US Congress, the Senate, may pass the bill next week.

According to the newspaper New York Times, a passage that would have made some fees from speaking engagements exempt from the requirement that doctors report payments from the pharmaceutical industry was removed at the last minute. Republican Senator Charles Grassley of Iowa, chairman of the Senate Judiciary Committee, is said to have urged the change.

Some think the removal of the controversial passage could help the bill’s chances of passing the Senate, where in particular Democratic Senator Elizabeth Warren of Massachusetts has fiercely opposed it. Speeding up FDA approval of new drug entities would potentially lower standards and “legalize fraud” by reducing the scientific evidence the government needs to approve existing drugs for new use, Warren has said.

Democrats are also unhappy that the new rules require funding to be appropriated annually instead of allowing it to roll over automatically each year. Health advocacy group Public Citizen also said in a position statement that without mandatory funding for the National Institutes of Health (NIH), for example, appropriators will have discretion over whether to release the funds each year, thus starting the bargaining process over and potentially forcing further concessions.

The act would provide fresh funding of $4.8 billion for NIH and $500 million to the Food and Drug Administration FDA over ten years. Public Citizen has urged that the Senate not pass the legislation “before there is time to thoroughly review it and understand the public health consequences.” While it said some “harmful provisions” have been improved or removed, it many “remain problematic.”