The 21st Century Cures Act, legislation that's been alternately hailed as a game changer for medicine and a gift to the pharmaceutical industry, is set to go to a vote in the House Wednesday, Nov. 30.
An earlier version of the bill, at 352-pages, gained House approval last year on a 344-77 vote but was delayed in the Senate. The latest version was rolled out this past weekend by Rep. Fred Upton R-Mich. and Senator Lamar Alexander R-Tenn. with an eye towards passing the bill before the end of the year. Upton and Lamar called the legislation "a transformational bill to bring our health infrastructure light years ahead."
The 996-page bill aims to pave the way for new drugs to gain faster approval from the Food and Drug Administration and provides $4.8 billion in new funding for the National Institute of Health, $500 million to the FDA as well as $1 billion to fund prevention of opioid abuse, and issue that has become critical in states like West Virginia, Kentucky and New Hampshire.
It also alters some of the medical device and drug approval and regulation process so that treatments could come to the market more quickly, in some cases relying more on anecdotal evidence rather than hard scientific proof, especially when there is an unmet medical need. It also opens the door to pharma companies receiving more market exclusivity for existing drugs that could be used for patients suffering from rare diseases, delaying the introduction of generic versions of drugs that are usually cheaper for patients to buy.