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Gary Heimberg

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Last year, Congress passed and President Biden signed into law the Inflation Reduction Act (IRA), which included provisions to allow Medicare to directly negotiate the price of drugs along with other cost control measures that, taken together, represented the most sweeping and impactful drug pricing policy reform in generations. “We finally beat pharma,” the President declared.

President Biden doubled down in his State of the Union address, repeating the mantra that Americans “pay more for prescription drugs than any major country on earth” – to back up his promise to veto any effort in Congress to repeal the IRA. Given the albeit slim Democratic majority in the Senate, the odds of legislation to repeal the IRA hitting the President’s desk in the next two years are nil. But putting political rhetoric aside, the reality is that the congressional environment for pharma remains threatening on a number of fronts.

Democrats in Congress continue to see drug pricing as a winning issue. Senate Finance Committee Chairman Wyden has essentially already rejected the idea of amending the IRA to put small molecule drugs on the same timeline for negotiation as biologics.  Wyden also recently sent a letter to the Centers for Medicare and Medicaid Services to make certain that the IRA’s inflation rebate provisions are timely and completely implemented. At the same time, as a counter balance, new House Energy and Commerce Chair McMorris Rodgers and others plan to use their oversight authorities to force transparency from Administration regarding the impact of the IRA on drug innovation and other issues.…

Continue Reading Drug Pricing Reform Efforts in DC: A Continuing Pill for the Biopharma Industry

The post-election Life Sciences policy menu can generally be described as lame duck leftovers and meaty oversight next Congress.

A number of “super riders” and other add-ons were  ultimately not included in the 5 year re-authorization of the various FDA user-fee acts (UFAs), “clean” versions of which passed in the current Continuing Resolution (CR).

Since the must-pass UFAs are typically a vehicle for other health policy related reforms, stakeholders were understandably disappointed – but remain hopeful of moving their priorities during the lame duck session.  

For what it is worth, there is some level of bipartisan support for attaching each of the super riders in the end of year package — including The VALID Act (Lab Developed Tests), Cosmetics reform, Dietary Supplement Reform, ARPA-H authorizing legislation and the PREVENT Pandemics Act — as well as a mental health package and targeted reforms that address, among other things, insulin pricing, clinical trial diversity and accelerated approval. But there are many competing priorities and time is short.

Next Congress will see attention to the landmark Medicare negotiations and other Rx price controls of the Inflation Reduction Act (IRA), which were unanimously opposed by the GOP.  Efforts to repeal writ large are a non-starter — though bills have been introduced to do just that. While some Republicans might recognize the need to make substantive changes, politically that could also be a non-starter because, like with the ACA, there will be resistance to making what in their minds is bad legislation marginally less bad.…

Continue Reading  Post-Election Life Sciences Policy Menu

The Affordable Care Act (ACA) has been an issue in every Congress since it was enacted in 2010 and this next Congress will be no different. There are so many health care issues that need to be debated—a national vs state pandemic strategy; funding for testing; additional relief for health care providers; surprise billing; treatment…

Consistent with popular predictions and our prior posts, Congress made drug pricing a key item on its investigative agenda in the first year of the 116th Congress.  Several factors contributed to the uptick in congressional drug pricing oversight activity, including the elevation of new Democratic chairs in the House with longstanding interests in drug…

Gary Heimberg delivered remarks during Covington’s post-election conference call with clients on November 8, 2018 on health care and drug pricing.  The health care segment follows:

 The Affordable Care Act has been an issue in every election since it passed in 2010.  This election was the first time the Democrats could fully embrace the law…

  • Drug pricing presents intriguing political dynamics. Whether and what policy prescriptions actually come to fruition in the next two years remain to be seen, but the rhetoric around the imperative to lower drug pricing — and the political pressure to act — will be more intense than we have seen to date.
  • President Trump and

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Today, the President will submit the Administration’s Fiscal Year 2019 budget blueprint to Congress.  The document will set in motion an annual process to analyze the substance, business implications and prospects for various proposals.  Draft documents have already begun to circulate that suggest that both the budget and a forthcoming addendum would, if enacted, have…

The post-election period — from the lame duck congressional session to the first 100 days and beyond of a new Administration and Congress — is expected to be a time of extraordinary, if not unprecedented, public policy debate on issues that impact pharmaceutical/life sciences companies and interest groups. These issues present both significant threats and…