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ACP continues to monitor legislation and provide comments to Congress to ensure transparency from manufacturers, reduction in prescription drug prices

Sept. 6, 2019 (ACP) – As Congress grapples with legislation to reduce the cost of prescription drugs, the �ܼ�����ˮ��̳ is continuing to make its views known to ensure that any legislation that moves forward is in the best interest of internal medicine physicians and their patients.

“It's too early to tell if Congress can reach an agreement on a major bill, but ACP remains committed to the enactment of legislation,” said Brian Buckley, ACP's senior associate for legislative affairs. “We believe Congress should lower the cost of prescription drugs by enacting policies that will promote competition in the pharmaceutical industry and increase transparency in the pricing and costs associated with the development of drugs and by implementing reforms to Medicare to lower out-of-pocket costs for seniors and increase the effectiveness of drugs in the marketplace.”

Prescription drug costs continue to skyrocket in the United States. A January 2019 report in Health Affairs revealed that the costs of brand-name oral prescription drugs rose by an average of more than 9 percent a year during 2008 to 2016, while the cost of injectable brand-name drugs increased by 15 percent per year. These increases were driven largely by existing drugs.

In July, the Senate Finance Committee passed the Prescription Drug Pricing Reduction Act, comprehensive, bipartisan legislation that includes several provisions to improve transparency in drug pricing by requiring drug companies to disclose additional information on their research and the development costs of their prescription drugs. This legislation “also makes substantial changes to the structure of Medicare Part D in order to simplify the benefit design and realign incentives to encourage more efficient management of drug spending,” Buckley said.

According to Buckley, the House of Representatives is expected to take up prescription drug pricing legislation, but it's not clear if the House will pass a bill that's significantly different than the Senate version. If the House and Senate bills conflict with each other, Buckley said, there may not be enough votes to resolve the differences so legislation can be signed into law.

ACP supports the following proposed bills:

• The Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act would amend the law to remove incentives for drug manufacturers to file excessive patents to keep generic drugs off the market and would lift legal barriers that delay generic entry into the market.
• The Prescription Drug STAR Act, which has been approved by the House Ways and Means Committee, would require manufacturers to publicly justify large price increases for existing drugs and high launch prices for new drugs. This legislation would set rules regarding disclosure of the aggregate rebates, discounts, and other price concessions achieved by pharmacy benefit managers (PBMs) on a public website, so consumers, employers, and other payers can understand and compare the discounts PBMs receive. It would also require all drug manufacturers to submit information about the average sales price for physician-administered drugs covered under Medicare Part B.
• The Medicare Prescription Drug Price Negotiation Act of 2019 would allow the federal government to negotiate covered Part D drug prices on behalf of Medicare beneficiaries.
• The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act would improve patient access to alternative low-cost prescription drugs and biological products by preventing prescription drug manufacturers from misusing the FDA's Risk Evaluation and Mitigation Strategies process to make it difficult for competing generics to be brought to the market. ACP signed a letter of support for this legislation, which has been approved by the House Energy and Commerce Committee.

What happens now? “First, House or Senate leaders need to rally support for a bill that can be passed in either chamber,” Buckley said. “Then we need to see the details of the bill to determine if ACP can support these policies and if they will truly lower the cost for our patients.”

Back to the September 6, 2019 issue of ACP Advocate