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Legislation to Speed Up FDA Approvals for Drugs and Medical Devices Likely to Become Law

Written by: Darren Young on Monday, December 5, 2016 Posted in: Home Infusion, Specialty Pharmacy

CMS Announces New Single Payment Amounts for DMEPOSLast week, by a large margin, the House approved H.R. 34, which is commonly known as the 21st Century Cures Act. The Senate is expected to consider—and pass—the bill this week, which includes spending of more than $6 billion over the next decade and has been described as the largest health reform since the Affordable Care Act. (1)

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With significant financial backing from pharmaceutical companies and medical schools on one side and multiple nonprofit patient advocacy groups on the other, this was the most heavily lobbied bill among the more than 11,000 proposed in this year’s Congress. (2) These groups were at odds, in part, because of the bill’s FDA reforms and funding, which now includes $500 million over 10 years for the FDA to hire more staff and speed the approval process of drugs and medical devices. Consumer advocates worry that these changes will expose patients to products that haven’t been properly tested by “weakening regulations on medical devices, allowing drugs to be approved with only limited evidence of the drug’s safety and efficacy, and rushing the use of new and unproven antibiotics.” (3)

The legislation also addresses provisions for mental health reform as well as $1 billion to go toward fighting the opioid crisis and funding for three programs favored by President Obama: the cancer moonshot, the BRAIN Initiative, and the Precision Medicine Initiative. As a result, if the Senate passes the bill, the president is expected to sign it. (4)

If concerns over proper testing of drugs and devices prove to have merit, your business management software can help you manage inventory in the event of recalls and monitor and report patient outcomes. Mediware’s new CareTend software equips you with the tools to keep your patients safe, whatever happens in Congress.

Sources:

  1. “House Just Passed the Biggest Health Reform Bill Since Obamacare”; Fortune; http://fortune.com/2016/11/30/house-passes-21st-century-cures/
  2. “‘Cures’ Act in Congress Heavily Influenced by Lobbyists”; Kaiser Health News; http://www.nbcnews.com/health/health-news/cures-act-congress-heavily-influenced-lobbyists-n689531
  3. “House approves the 21st Century Cures Act, sending landmark bill to Senate”; Stat; https://www.statnews.com/2016/11/30/21st-century-cures-act-house/?_hsenc=p2ANqtz-_ZA6QfMIXeBggfvazBzNOT6cj9qhcZx0VIrx6bJO5zn16DtyXWsQYDUnzE8h_xDX4xRNlo0NpInxjU9CBcmVfrLD982Iaig2WYglKeqziBIEjPa3k&_hsmi=38528850
  4. Statement by the Press Secretary on H.R. 34, the 21st Century Cures Act; https://www.whitehouse.gov/the-press-office/2016/11/30/statement-press-secretary-hr-34-21st-century-cures-act