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Monthly Legislative Newsletter: July 2021
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Drug Pricing Update

On June 22, 2021, Senate Finance Committee Chairman Ron Wyden (D-OR) released his comprehensive “Principles for Drug Pricing Reform” document that builds off of the legislation he introduced with Senator Chuck Grassley (R-IA) in the 116th Congress. His proposal is largely in response to H.R. 3, the comprehensive drug pricing reform package introduced in the House of Representatives earlier this year. Chair Wyden’s package, which does include things such as Medicare negotiated drug prices, capping out of pocket costs for Medicare beneficiaries, and limiting price increases to the rate of inflation does not reach as far as the House Democrats’ proposal in an effort to bring together the moderate and progressive wings of the Democratic party.

For Chair Wyden, it is necessary to propose legislation that can unite all wings of the Democratic Party because it is unlikely that any comprehensive drug pricing legislation that includes Medicare negotiated prices will get any Republican support. Additionally, Democrats will need to utilize a budget reconciliation bill to get the legislation passed, which will require all 50 Democratic votes in the Senate.

You can view Chair Wyden’s proposal HERE.

While Congress has yet to come to an agreement as to what comprehensive drug pricing reform will look like, Americans and even those in the pharmaceutical industry believe something needs to be done to lower prices. PhRMA Chief Operating Officer Lori Reilly recently stated during a Milken Institute panel that “As long as we ensure that those costs go to patient ability to access their medicines, and keep the balanced ecosystem that we believe is in place today as it relates to innovation, we're absolutely willing to partner with anyone to have those conversations.” This is a significant shift in traditional thinking as it was widely thought that the drug industry would fight any effort to lower drug prices.

PRG will continue to monitor the drug pricing conversation and provide updates as necessary.

ARPA-H Update

Inside and outside of government there is a growing concern about where ARPA-H will be housed as it is being widely reported that the new agency will be within the National Institutes of Health. Many are concerned about creating a duplicative bureaucratic process with some of the same problems that plague the current NIH research system. Should ARPA-H be bogged down by some of the same issues as NIH, it is unlikely that ARPA-H will have the freedom and flexibility that was billed when the Biden administration proposed the new agency. On the other hand, the administration believes that ARPA-H being included in NIH will allow ARPA-H to have the foundation to hit the ground running to achieve its lofty mandate, similar to the Department of Defense’s Defense Advanced Research Projects Agency.

Both Secretary of Health and Human Services Becerra and NIH Director Collins have come out in support of ARPA-H, stating that the new agency will have its own identity separate of other research opportunities within NIH.

All discussion on ARPA-H in recent HHS budget hearings is available in the Congressional hearings section below.

CURES 2.0 is Here

On June 22, 2021. Reps Diana DeGette (D-CO) and Fred Upton (R-MI), who led the first iteration of the 21st Century Cures Act, released draft legislation that would create a new federal advanced research agency to cure cancer, Alzheimer’s and other diseases. In addition to realizing the President’s dream of creating ARPA-H, the legislation would:

  • Improve how Medicare covers innovative new health care technologies, making them more available to those who need them.
  • Increase diversity in clinical trials to ensure new drugs and treatments are both safe and effective for a greater majority of patients throughout the country.
  • Require FDA to expand the collection and use of Real World Evidence to aid in the development of new, patient-focused treatment approaches.
  • Provide training and educational programs for caregivers – many of whom are often family members with no prior health care experience – to help improve the quality of care patients are provided at home, between clinical visits.
  • Provide patients greater access to more health information to improve their understanding of the illness they face and make them a more integral part of the decision-making process when assessing which course of treatment is best for them.
  • Increase access to telehealth services for patients covered under Medicare, Medicaid or the Children’s Health Insurance Program (CHIP) to make these services more accessible to more Americans.

You can view a section-by-section summary of the legislation HERE.