May 16, 2019
“The CREATES Act is good, bipartisan policy that will lower prescription drug prices for Americans—which is why I am the lead Republican sponsor of the bill. Unfortunately, in a blatant partisan play, the Democratic leadership has attached CREATES to the so-called ‘Strengthening Health Care and Lowering Prescription Drug Costs Act.’ This move showcases the main problem in Washington—scoring political points instead of helping the American people.
H.R. 987 would bail out a failing Obamacare system, but it stands no chance of becoming law. It’s incredibly disappointing that Democratic leadership chose to play politics rather than legislate. Lowering prescription drug prices is one of my top priorities this year. We could accomplish that with the CREATES Act. Instead, we saw a clear political stunt today and are no closer to helping the American people.”
Background on H.R. 987:
H.R.987 combines three bipartisan drug pricing bills with four partisan Obamacare bailout bills. They are: H.R. 965, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act; .R. 1499, the Protecting Consumer Access to Generic Drugs Act; H.R. 938, the Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act; H.R. 1385, the State Allowance for a Variety of Exchanges (SAVE) Act; H.R. 1386, the Expand Navigators' Resources for Outreach, Learning, and Longevity (ENROLL) Act; H.R. 1010, To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect; and H.R. 987, the Marketing and Outreach Restoration to Empower Health Education Act.
Congressman Sensenbrenner voted for Amendment #2, which would have stripped the provisions aimed at bailing out Obamacare and retained the prescription drug price language. The amendment’s failure led to Sensenbrenner ultimately voting no on H.R. 987.
Background the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act:
In order for a generic or biosimilar prescription to have FDA approval, the generic manufacturer must be able to compare its product to the brand-name product. Simply put, if the product is as safe and effective as the label, then the FDA can approve the generic.
Some generic manufacturers, however, have difficulty obtaining samples of medication from the brand-name company. This is because brand-name companies have an incentive to make it difficult for generic producers to obtain their brand-name products.
The CREATES Act gives generic manufacturers the ability to bring actions in federal court against brand-name companies that refuse to provide samples of their products for purchase and use in the generic approval process. In so doing, the CREATES Act helps to increase the likelihood of a generic product coming to the market so consumers have more affordable options.
The CREATES Act also gives the FDA more discretion for approving alternative safety protocols that meet the statutory standards already in place. This helps the FDA more efficiently process generic applications. In the end, this helps consumers, who will have greater choice when selecting their medications.
According to a Congressional Budget Office estimate, the CREATES Act will save the federal government $3.9 billion on prescription spending.
More than 90 organizations representing consumers, physicians, pharmacists, hospitals, insurers, antitrust exports, and others support the CREATES Act. Supporters include AARP, Campaign for Sustainable Rx Pricing, Consumer Reports, Public Citizen, American Hospital Association, America’s Health Insurance Plans, Patients for Affordable Drugs, and the Coalition for Affordable Prescription Drugs.