Collins statement on markup of CREATES Act

". . . if the branded manufacturer denies the provision of samples, it can delay its competitor’s approval and prop up its own drug’s high costs. This should not be happening. . . . The CREATES Act will prevent this kind of gaming and make sure that generic and biosimilar manufacturers can gain samples to complete testing and win FDA approvals."

WASHINGTON — Rep. Doug Collins (R-Ga.), Ranking Member of the House Judiciary Committee, made the following opening statement at the markup of H.R. 965, the CREATES Act. Below are the remarks as prepared. Ranking Member Collins: I thank Subcommittee Chairman Cicilline and Ranking Member Sensenbrenner for introducing this important bill. Competition from generic and biosimilar prescription drugs is one of the key ways to lower prescription drug prices, but before a generic or biosimilar drug can enter the market, its manufacturer has to gain FDA approval. To do that, the manufacturer has to obtain samples of the branded drug with which it intends to compete, so it can perform tests to show the FDA that its product also should gain entry to the market. And therein lies the rub – if the branded manufacturer denies the provision of samples, it can delay its competitor’s approval and prop up its own drug’s high costs. This should not be happening. Our laws are written to allow generic and biosimilar manufacturers to compete and lower drug prices for the benefit of consumers. True, they also are written to protect the legitimate rights of innovative branded manufacturers – but that does not include rights to game the system to keep competition wrongfully out and consumer drug prices artificially high. The CREATES Act will prevent this kind of gaming and make sure that generic and biosimilar manufacturers can gain samples to complete testing and win FDA approvals. It does so in a very simple and straightforward way – it allows generic and biosimilar manufacturers to bring antitrust suits against branded manufacturers that wrongfully withhold their samples. In these suits, courts can order branded manufacturers to provide the samples. If justified, courts can also award the generic or biosimilar manufacturer damages based on the revenues the branded manufacturer reaped while wrongfully withholding the samples. These are consequences that should make clear to branded manufacturers from the get-go that there is no benefit to be had from trying to game the system and deny samples. As a result, this legislation should bring this anticompetitive behavior to a grinding halt. The Congressional Budget Office has estimated that the CREATES Act will save the federal government $3.9 billion in prescription spending. It should lower prescription drug costs even more when non-government spending is taken into account. This is strong relief for Americans suffering from the burden of excessively high prescription drug costs. I am cosponsor of this legislation and urge all of my colleagues to support the bill.