Sens. Chuck Grassley (R-Iowa) and Patrick Leahy (D-Vt.) reintroduced the Creating and Restoring Equal Access to Equivalent Samples Act, or Creates Act, which generated immense opposition from the pharmaceutical industry.
“For too long, a few predatory name brand companies have used anticompetitive strategies to delay entry of lower cost generic drugs,” Leahy said in a statement. “When these companies use unfair practices to keep drug prices artificially high, patients suffer.”
The bill tackles several tactics that brand-name companies use to deny samples to generic companies, which need sometimes up to 5,000 samples of a drug to use for testing before they can score U.S. Food and Drug Administration regulatory approval.
Brand-name companies also deny access to samples by invoking a distribution safety protocol known as Risk Evaluation and Mitigation Strategies that certain high-risk drugs get from the FDA.
If the bill passes, it would allow a biosimilar or generic-drug manufacturer to sue in federal court for an injunction to obtain the samples it needs, according to a summary of the bill.
The legislation also gives the FDA more discretion to approve alternative safety protocols to ensure that a brand-name company cannot use the protocol as a shield to delay access to samples.
The bill was introduced in the last Congress. It had wide bipartisan support but never advanced in the House or Senate after staunch opposition from the pharmaceutical industry.