21st Century Cures Invites Criticism From Medical Device Injury Lawyers

female patient with doctor

National product liability lawyers of The Sanders Firm support many of the concerns raised by consumer watchdog group, Public Citizen, regarding the recently enacted 21st Century Cures Act. Also known as H.R. 6, the bill was passed unanimously last month with the aim of expediting the approval of new drugs and medical devices, while bolstering healthcare innovation in the United States.

The new legislation has many proponents, including medical organizations, the pharmaceutical industry and some patient advocacy groups. However, the bill’s long catalog of provisions that will substantially change the way new medications and devices are approved has sparked serious concern from watchdog groups and notable physicians who believe the Act has the potential to harm vulnerable patients.

As veteran attorneys on the forefront of medical device injury litigation across the nation, The Sanders Firm has witnessed the catastrophic impact that dangerous and defective products have on innocent lives.  The FDA’s already lax regulatory oversight of new devices and drugs has been the topic of scrutiny for many years; and as proposed, many of the bill’s new provisions may further undermine this process to the detriment of consumer safety.

Indeed, the 21st Century Cures Act is viewed by some critics as a double-edged sword. While it may speed up the development of life-saving drugs for people in dire need, the law “increases funding for the world-renowned NIH in exchange for providing perks for the pharmaceutical and medical device industries,” says Vijay Das, a healthcare advocate at Public Citizen.

21st Century Cures Act promotes “dangerous regulatory changes”

Over the next five years, the National Institutes of Health will receive over $8.75 billion as part of the bill. This massive funding is dedicated to advanced biomedical studies, and further research into breakthrough treatments for rare conditions and diseases. Given the importance of NIH-funded research for novel drug therapies, this innovation fund has been heralded by many in the medical community.

However, Public Citizen cautions that the bill also promotes “dangerous regulatory changes and financial incentives for pharmaceutical and medical device companies.” For example, Section 2222 of the Act would enable the FDA to fast track the approval process for new high-risk medical devices based purely on medical journal reports and case studies, which may leave out critical data and anecdotes pertinent to long-term safety and efficacy.

Section 2221 of the bill would enable manufacturers to make changes to these high-risk devices without prior safety testing or FDA notification.

Public Citizen also notes that language within the legislation gives hospitals financial incentives to use newly developed antibiotics, having the potential to accelerate the growth of antibiotic-resistant superbugs.

Additionally, the watchdog group states that under Section 3041, the Act would allow medical and pharmaceutical manufacturers to have undue influence over physicians and medical education by allowing these companies to omit gifts or speaking fees paid to doctors that are planned for “continuing medical education” purposes.

Leading medical device injury lawyers

While the 21st Century Cures Act has achieved bipartisan support for its potential to streamline the development and approval of new prescription medications and devices, these changes may ultimately put consumer safety at risk.

Representing victims of dangerous drugs and medical devices for more than 45 years, The Sanders Firm believes that patient safety should always come first, even if it requires more lengthy and extensive FDA oversight. If you or a loved one has been harmed by a defective medical device, you may be entitled to compensation. Call us at 1-800-FAIR-PLAY to discuss your options for filing a medical device injury lawsuit. The consultation is free, and we only get paid when you do. Resources

  1. Public Citizen, REPORTERS’ MEMO Don’t Buy the Snake Oil: 21st Century Cures Would Reduce Safety of Medications and Devices https://www.citizen.org/pressroom/pressroomredirect.cfm?ID=5579
  2. Washington Post, House overwhelmingly passes bill to speed FDA drug approvals https://www.washingtonpost.com/news/wonkblog/wp/2015/07/10/house-overwhelmingly-passes-bill-to-speed-fda-drug-approvals/

Beckers Hospital Review, 10 things to know about the 21st Century Cures Act https://www.beckershospitalreview.com/healthcare-information-technology/10-things-to-know-about-the-21st-century-cures-act.html