Will faster drug approvals put unsafe meds on the market?

Breakthroughs in medical research may come at a frenetic pace, but the process to get new innovations to market is often slow and tedious. The 21st Century Cures Act may change that, but critics fear the bill, just passed by the House of Representatives in a landslide, 344-77 vote, will compromise consumer safety and increase healthcare costs.

The legislation, supported by the White House and medical societies such as the American College of Surgeons and the American Heart Association, speeds up the regulatory process and shortens review times to accelerate the development and approval of new drugs and medical devices.

The Cures Act is “monumental legislation that will accelerate the discovery, development, and delivery of promising new treatments to people living with cancer,” Julie Vose, president of the American Society of Clinical Oncology, said in a statement.

But other experts say the bill will allow inadequately tested drugs and medical devices on the market and could increase healthcare spending on drugs and products that are ineffective or outright harmful.

“Shortening review times is not going to create the scientific understanding and the research and development that needs to be done to translate exciting opportunities in science into new products,” former FDA commissioner Margaret Hamburg told Modern Healthcare.

The legislation greatly benefits the pharmaceutical industry and medical device manufacturers, Diana Zuckerman, president of the National Center for Health Research, a think-tank focused on women, children, and families, told Medscape.

“But by lowering standards for drugs and devices, it is likely to add billions to the cost of Medicare and all health programs without benefitting most patients,” she said. “And it is an added burden on patients and physicians, because they need to decide which of the new treatments to try, without knowing if they are safe and effective.”

The Cures Act offers incentives for drug makers by lengthening the time a new drug is under patent protection. Current legislation allows a maximum patent protection of 12 years for new biologic drugs, five years for new chemical drugs, and seven years for orphan drugs.

The new legislation gives manufacturers market exclusivity for up to 15 years for any product intended to treat at least one unmet need. Such a broad parameter means most new drugs will meet the criteria for longer market exclusivity, forcing consumers to wait longer to get access to the cheaper generic drugs, Arthur Caplan, a bioethicist at New York University’s Langone Medical Center told Modern Healthcare.

The bill also accelerates the regulatory process by allowing researchers to use more surrogate endpoints, a measure used in a clinical trial as a substitute for the outcome that demonstrates the effect of a drug or intervention. For example, in a clinical trial of a drug designed to decrease heart attacks, researchers may be allowed to forgo waiting to see if the patients taking the drug actually suffer fewer heart attacks by substituting evidence the drug lowered cholesterol levels, which presumably would decrease the incidence of heart attacks.

But surrogate endpoints cannot predict a drug’s long-term risks.

“There’s just no way that you can use substitute endpoints and not create more risk for people down the road,” Caplan said. “It’s just not as reliable. You get speed, and that’s good. But you up the risk.”

The bill will go to the Senate later this year.