Hart Health Strategies provides a comprehensive policy briefing on a weekly basis. This in-depth health policy briefing is sent out at the beginning of each week. The health policy briefing recaps the previous week and previews the week ahead. It alerts clients to upcoming congressional hearings, newly introduced bills, regulatory announcements, and implementation activity related to the Patient Protection and Affordable Care Act (PPACA) and other health laws.


Biden Signs EO on Competition in U.S. Economy and Pharmaceutical Market

President Joe Biden signed an executive order (EO) on Friday to encourage competition across the U.S. economy, with a specific focus on the agriculture, technology, and pharmaceutical markets. According to the White House, the President aims to break up concentrated markets and reverse the trends of consolidation that the White House believes has weakened markets and widened racial, income, and wealth inequality. The EO includes 72 initiatives to be implemented by more than a dozen federal agencies. The U.S. Department of Health and Human Services (HHS) is directed to develop a plan within 45 days to counter high drug prices and to increase support for generic and biosimilar drugs. The Food and Drug Administration (FDA) is directed to work with states to import prescription drugs from Canada. The EO also directs the Federal Trade Commission (FTC) to ban pay-for-delay agreements and other similar agreements that can impact competition for low-cost treatment options for patients.

House Dems Release Report on Drug Company Finances

Democrats on the House Oversight and Reform Committee released a staff report last week analyzing the financial data of the nation’s largest pharmaceutical manufacturers. The report details manufacturers’ buybacks and research and development (R&D) spending, finding that the top 14 drug companies spent $577 billion on buybacks and dividends, $56 billion more than the amount spent on R&D. The report also examines pharmaceutical executives’ salaries at the times that companies raised the prices of their medications. The report aims to undermine industry’s argument that reducing prescription drug prices will negatively impact innovation in the development of new treatments and cures. House Speaker Nancy Pelosi (D-Calif.) stated last week that she will push to attach Democrat’s signature drug pricing legislation (H.R. 3) to the economic/infrastructure package expected to move via the budget reconciliation process later this year. Drug pricing provisions were not initially included as a part of the President’s American Jobs and Families Plan agenda but were included in Senate Budget Committee Bernie Sanders’ (I-Vt.) draft $6 trillion budget resolution for the forthcoming fiscal year as a means to pay for Medicare expansion. Pelosi noted that she is working with colleagues in both the House and Senate to draft a version of H.R. 3 that could garner unified Democratic support.

Schumer Previews Senate Agenda in Advance of August Recess

In a Dear Colleague letter to members of the Senate, Majority Leader Chuck Schumer (D-N.Y.) outlined his agenda for the chamber’s upcoming work period. The Senate will continue its work to pass the American Jobs and Families Plan. Schumer describes the two paths being taken to advance the President’s infrastructure priorities. On the bipartisan infrastructure path, committees are working together with the White House and the bipartisan infrastructure group to convert their recent agreement into legislation. The second track consists of work being done by the Senate Budget Committee on a fiscal year (FY) 2022 budget resolution that will be used to enact the remaining elements of the American Jobs and Families Plan – relating to climate change, health care, and the caring economy – through the budget reconciliation process. Schumer states that senators “should be prepared for the possibility of working long nights, weekends, and remaining in Washington into the previously-scheduled August state work period.” White House officials are pushing for a Senate vote on the bipartisan infrastructure deal as early as the week of July 19. As it currently stands, the plan is still just a framework agreed upon by a bipartisan group of 20 senators who continue to hammer out the details of turning their proposals into legislative text.

CBO Update to the Budget and Economic Outlook: 2021 to 2031

The Congressional Budget Office (CBO) has released its latest publication presenting projections of federal budget deficits, debt, revenues, and spending for the current year and for the following 10 years if current tax and spending laws remain unchanged. The agency finds that the federal budget deficit will total $3.0 trillion, federal debt will reach 103% of gross domestic product (GDP) in fiscal year (FY) 2021, and real GDP will grow by 7.4% in calendar year 2021. CBO is expected to release more detailed information about its projections later this month.

CDC, FDA Comment on Need for Booster Shots

Individuals that have been fully vaccinated against COVID-19 do not need a booster shot at this time, according to a joint statement from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) on vaccine boosters. The National Institutes of Health (NIH), along with the CDC and FDA, remain “engaged in a science- based, rigorous process to consider whether or when a booster might be necessary,” and are “prepared for booster doses if and when the science demonstrates that they are needed.” The agency stresses that people who are unvaccinated remain at risk of severe disease and death, including from variants currently circulating around the country like the Delta variant. The joint statement may have been in response to a Pfizer-BioNTech press release related to their proposed third dose booster.

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