CREATES undermines critical drug safety regulations

“It ain’t over till it’s over.” Yogi Berra’s famous saying has new relevance now that Congress may add the Creating and Restoring Equal Access to Equivalent Samples Act (CREATES), to the omnibus spending package, despite the warnings of leading patient safety advocates.

Long ago, I pitched for the San Francisco Giants and Kansas City Royals. What I learned from baseball is the validity of Yogi’s words: Every play counts, every inning matters and players and managers are trained not to make judgements too soon.

{mosads}Now, as a college professor living with an incurable blood cancer called multiple myeloma, I see the relevance of Yogi’s wisdom for lawmakers who view CREATES as an offset to some federal spending. What I worry is that in pursuit of budget cost savings, Congress may jeopardize the safety of life-saving medications patients depend on for treatment.

CREATES is billed as a way to save the health system approximately $3 billion over 10 years by increasing the availability of generic drugs. But accomplishing this goal requires undermining critical drug safety regulations called Risk Mitigation and Evaluation Strategies (REMS) so generic drug companies can obtain samples of REMS drugs for comparative testing.

Proponents say this tradeoff is needed because drug companies routinely misuse strict REMS procedures to ward off competition. They also claim forcing the sale of high-risk REMS drugs to generic companies will “strengthen” the REMS system and help reduce federal spending.

Due to media reports, members of Congress may assume these claims are true and that CREATES has widespread support. But patient organizations in the U.S. and Europe are challenging the common wisdom about CREATES and raising serious safety concerns. This is what patient advocates want Congress to know.

First, Congress gave the Food and Drug Administration (FDA) the authority to mandate REMS controls and for a very important reason: Without these safeguards, needed medicines would not be on the market today due to their potential harmfulness.

This includes the first gene therapy available in the country and treatments for 26 diseases, including cancer, Crohn’s disease, kidney disease and multiple sclerosis.

REMS restrictions are necessary is to prevent the terrible consequences if medicines known to cause birth defects, organ damage, serious infections and even death are not carefully controlled. One example is the drug thalidomide, responsible for over 10,000 babies being born in the 1950s and 1960s with severely deformed appendages.  Even today, babies in Africa, Brazil and India are born with these birth defects when thalidomide is not strictly regulated.

Similarly, rigorous REMS controls are necessary to stop drug diversion, especially now that that nation is facing a growing opioid addiction crisis. According to White House estimates, the true cost of the opioid drug epidemic in 2015 was $504 billion. This price tag could rise if Congress inadvertently lowers the safety standards that keep opioids from getting into the wrong hands.

There is also a question as to whether CREATES is actually needed to achieve the savings to the federal government anticipated by lawmakers. According to the FDA, the agency approved 1,027 generic drugs in 2017 — 214 more than the previous record of 813 set in 2016.

Finally, patient advocates want lawmakers to know that ensuring safe medicines and increasing generic drug development can go hand in hand if Congress requires all drug developers — branded companies and generic manufacturers — to follow the same safety protocols when testing and marketing high-risk drugs.

Right now, CREATES lets generic developers opt for so-called “comparable” precautionary procedures and curbs FDA’s ability to verify a generic company’s safety record.

The FDA earned its stellar reputation by keeping thalidomide out of circulation in the U.S. Saying that generic company versions of REMS tests may be “comparable” is not enough. The testing must be proven to be as good or better to avoid any possibility of a repeat of the horrible tragedy of 60 years ago.

Simple legislative changes can correct these problems. Instead of using CREATES as a budget offset, Congress should fix the problems with CREATES so it really is a win for patients.

Bob Tufts is a former major league baseball player, is a clinical assistant professor at Yeshiva University Sy Syms School of Business and is a cancer survivor working with Patients Rising to advocate for better access to quality cancer care.