If I told you Republican Senators Mike Lee (R-UT) and John McCain (R-AZ), came together with Democratic Senators Diane Feinstein (D-CA) and Patrick Leahy (D-VT)—among others—to sponsor a bill, would you believe it?
The Creating and Restoring Equal Access to Equivalent Samples Act of 2017 (or CREATES Act) brings Senators from across the political spectrum together. The bill has the potential to bring down prices for government and consumers by encouraging competition in the drug market.
Under FDA regulations, drug companies are legally required to provide samples to FDA-approved generic companies when requested once a drug patent expires so that generics can prove their safety. FDA regulations also require that manufacturers participate in Risk Evaluation and Mitigation Strategies—or REMS—when dealing with dangerous and possibly fatal drugs, but brand-name manufacturers often refuse to share samples or let competitors participate in shared safety protocols.
With CREATES, generic manufacturers have a path to relief if companies refuse to sell samples of the drugs or participate in REMS.
Now, we’re hearing that the bill may be used as a pay-for to reauthorize the Children’s Health Insurance Program (CHIP) at the end of the month. While full details and potential savings are not yet known, this is an encouraging opportunity to see much-needed reforms that both sides can support, at a time when Congress seems to butt heads on nearly every other issue.