Consumer groups are cautioning against approval of a medical innovation bill moving toward passage in the House and Senate, warning that it could endanger patients by lowering standards for the approval of new drugs.
The 21st Century Cures Act would also provide $1 billion over 2 years to combat opioid abuse, including expanding access to treatment programs.
The bill would also require the FDA to evaluate the use of "real world" evidence to support new uses and post-approval studies for previously approved drugs, as opposed to the gold standard of randomized clinical trials.
Healthcare stakeholders have touted the health IT provisions of the bill, particularly regarding the Food and Drug Administration's oversight of the sector, as well as encouraging interoperability of electronic health records (EHRs) and patient access to health data, and discouraging information blocking.
The 21st Century Cures Act set for a House vote Wednesday is one of the most-lobbied health care bills in recent history, with almost three lobbyists working for its passage or defeat for every member on Capitol Hill. Lamar Alexander (R-Tenn.) released a final draft of the 21st Century Cures Act late last week, which would provide more than $4.8 billion over a decade to the National Institutes of Health for the Precision Medicine Initiative, the BRAIN Initiative and the Cancer Moonshot, as well as for regenerative medicine.
President-elect Donald Trump has vowed to eliminate "red tape" at the FDA but hasn't specifically commented on the Cures Act. He has not remarked explicitly on 21st Century Cures.
Other than major appropriations bills, a transportation spending bill and an energy infrastructure funding bill, the Cures Act garnered more lobbying activity than any of the more than 11,000 bills proposed in the 114th Congress, an analysis of the CRP data shows. "Companies are trying to funnel money in whatever way they can in order to continue to get docs to accept the money", he said.
Samsung Galaxy S8 Rumored to Sport 6G RAM, 256GB Storage Option
According to recent reports uploaded by Weibo , it is rumored that the Samsung Galaxy S8 will possess the Snapdragon 835 chip. Samsung's upcoming flagship, the Galaxy Note 8 is slated to feature Artificial Intelligence as well as removable batteries.
She said it comprises too much give-aways to the pharmaceutical industry and will let companies promote treatments with limited proof of efficacy.
"This final deal has only a tiny fig leaf of funding for NIH and for the opioid crisis", she said on the Senate floor.
Additional lobbyists may be working on the bill under the radar, according to Tim LaPira, a political science professor at James Madison University.
Hospitals and medical schools, which oppose rising drug costs, supported the bill because the NIH funding could propel grants to medical and research institutions, Zuckerman said.
Wednesday, November 30: The House Committee on Energy and Commerce Subcommittee on Health will hold a hearing titled "USPSTF (United States Preventive Services Task Force) Transparency and Accountability Act of 2016". He explained that lax lobbying disclosure requirements mean that some lobbyists may not disclose work on the bill, H.R. 6.
House and Senate health committee leaders released a final version of the legislation over the holiday weekend, on Friday, Nov. 25.
"We are pleased to see that the bill retained language instructing GAO to investigate and report on patient matching".