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21st Century Cures Act Threatens Patient Safety, Critics Say

Bill would eliminate third stage of clinical testing for some drugs

Opponents of the 21st Century Cures Act, which is intended to accelerate the transfer of scientific advances in genetics into treatment for patients, say the legislation will threaten patient safety by easing FDA rules intended to protect patients from unproven therapies, according to a report in Medical Economics. The act was passed by the House of Representatives in July 2015 and is making its way through the Senate.

Supporters say the bill will lead to more medications being available for patients, a positive development. But opponents say the bill could jeopardize patient safety by allowing drug approvals without the level of rigorous testing now required. If passed, the new legislation will let the FDA eliminate a third stage of clinical testing for a new drug if its second-stage testing shows significant efficacy.

Opponents also argue that the drugs coming to market will be high-priced specialty products and will therefore lead to higher overall drug costs for the U.S. health care system. That could produce a squeeze on physicians’ reimbursements from Medicare and Medicaid as those programs seek savings in other areas to compensate for higher drug spending.

James Rickert, president of the Society for Patient Centered Orthopedic Surgery, told Medical Economics that if the act becomes law, physicians will need to do their homework when it comes to using newly approved treatments. “Doctors are actually going to have to read the package insert” and schedule time with pharmaceutical reps to learn about new offerings, he said.

The American Academy of Family Physicians (AAFP) hasn’t take a position on the act, seeing both good and bad in it, according to the group’s president-elect, John Meigs, MD. The AAFP is hoping, however, that Congress will address the interoperability of electronic health records (EHRs). The 21st Century Cures Act mandates that all patient information must be transferrable from one certified EHR system to another.

Today, “interoperability is not there; the systems are not where they need to be,” Meigs said. Vendors who fail to meet interoperability standards should be financially penalized, he asserted. Currently, doctors are penalized if their systems fail to meet meaningful- use requirements regarding interoperability. “The problem is with the vendor, and it’s the providers that are being held accountable,” Meigs said.

Source: Medical Economics; December 25, 2015.

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