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House Judiciary Committee Advances CREATES Act, Three Other Drug Pricing Bills; Energy and Commerce Health Subcommittee Holds Hearing on Rising Cost of Drugs in Medicare

At an April 30 mark-up session, the House Judiciary Committee advanced four bills aimed at reducing prescription drug prices. All four bills passed unanimously and without amendment, including the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, (H.R. 965), which would promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products—and allow generic and biosimilar developers to sue brand-name manufacturers for withholding samples; the Preserve Access to Affordable Generics and Biosimilars Act (H.R. 2375), which would forbid drug companies from paying other companies to keep generics or biosimilars off the market; the Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics (STALLING) Act (H.R. 2374), which would allow the Federal Trade Commission to crack down on “sham” citizen petitions designed to keep generics or biosimilars off the market; and the Prescription Pricing for the People Act of 2019 (H.R. 2376), which would require the Federal Trade Commission to put together a comprehensive study of the role of intermediaries, such as pharmacy benefit managers, in the prescription drug supply chain.

The House Energy and Commerce (E&C) Committee, which also has jurisdiction over the CREATES Act, passed the bill in early April with bipartisan support. The legislation now heads to the full House for a vote, as does the Stop STALLING Act. The remaining two bills passed by Judiciary are still in the hands of the E&C Committee.

Also on April 30, the House E&C Health Subcommittee held a hearing, “Prescription Drug Coverage in the Medicare Program,” to examine the rising costs of prescription drugs in Medicare. Testifying before the committee was James E. Mathews, PhD, executive director of the Medicare Payment Advisory Commission (MedPAC).

In her opening remarks, Health Subcommittee Chair Anna Eshoo (D-CA) noted that “Medicare accounts for one out of every three dollars spent on prescription drugs, and drug spending is growing rapidly each year,” whether patients get their drugs at the hospital under Part B or at the pharmacy counter under Part D. She also pointed out that Medicare spending on drugs in specialty tiers has grown nearly 1,000% over 10 years, from $3.4 billion in 2007 to $37.1 billion in 2017. 

One issue discussed during the hearing is whether the current formula for Part B drug pricing creates incentives for higher-cost drugs. “Medicare payments for high-cost Part B drugs are based on the manufacturer’s average sales price (ASP) to physicians, hospitals, and other purchasers plus a 6% add-on,” Dr. Mathews noted in his testimony.

For more information on the hearing, including witness testimony, or to watch the hearing in its entirety, visit the E&C hearing website.

We will keep you updated.

 

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