Docs: 21st Century Cures measures make drugs, med devices 'less safe and effective'

The road the 21st Century Cures Act has traveled has not always been smooth, and as the Senate prepares to take it up this fall, there are still obstacles in its path.

While there has been optimism surrounding the legislation, mostly in the House, the fervor around the bill "obscures measures buried within that many agree will make newly approved drugs and medical devices less safe and effective, increase the cost of medical products, and discourage innovation in biomedical research," Susan Molchan, M.D., James Rickert, M.D., and John Powers, D.M.D, write in the Health Affairs Blog.

The health professionals say the bill sacrifices long-term value to public health through faster approval by the U.S. Food and Drug Administration for medical devices and drugs. They add that the legislation largely favors the pharmaceutical, biotechnology and medical device industries, instead of focusing on the needs of patients.

Privacy advocates also recently came out against the legislation, which was authored by a group of bipartisan lawmakers.

Kirk Nahra, partner at law firm Wiley Rein, said language for one provision in the bill allows a hospital to share all research conducted as part of a hospital's operations with any other covered entity, such as another hospital, pharmaceutical company or insurer. Another provision allows disclosures of health information for research purposes to pharmaceutical companies and medical device makers, he said.

The bill is "more of the same old, same old measures to increase the spread and use" of personal data while taking control out of patients' hands, patient privacy advocate Deborah Peel, M.D., said in July.

One of the most worrisome parts of the law, according to Molchan, Rickert and Powers, is what they call "an unnecessary" pathway to fast-track FDA approval of antibiotics based on non-clinical data and early-stage clinical trials. The bill also says hospitals must be paid extra when they use new antibiotics instead of older, available ones; that may cause the unnecessary use of new antibiotics, they write.

It is not a done deal that the optimism toward the bill shown in the House will carry over to the Senate. In fact, the bill may be DOA when it hits the floor, as it has seen little momentum since its House passage.

To learn more:
- here's the Health Affairs Blog post