Capitol Perspectives

- A pharmaceutical regulatory insider, John McManus, provides best practice insights and opinions regarding FDA guidance/initiatives.

• Bloated COVID Relief Package Misses Mark

  In his final column, John McManus discusses the difficult position pharma companies are in now from a political standpoint and the COVID relief bills.

• New Swipes At Rx Industry Despite Stable Costs

  2/8/2021

  On the last full day of President Trump’s tumultuous presidency, CMS released a proposal to dramatically restrict access to Part D drugs for patients with serious medical conditions.

• Most Favored Nation Pricing Temporarily Halted By Courts

  1/14/2021

  In late December, the courts halted President Trump’s international reference-pricing scheme, the Most Favored Nation model, saying the administration had improperly attempted to implement a radical change in Medicare reimbursement policy.

• Most Favored Nation Regulation Could Upend The Rx Market

  12/9/2020

  Buried on page 184 of President Trump’s interim final rule (IFR) implementing his “Most Favored Nation” (MFN) drug proposal is Table 11, which projects 19% lower utilization of Medicare Part B medications due to “no access.” 

• Election Fallout: Can Divided Government Forge Bipartisan Solutions?

  11/10/2020

  As the election concludes, we still face new changes to healthcare policy, pharma price-controls, taxes, and a staggering debt.

• Implementation Of MFN, Importation, And Other Mischief In 2020

  10/12/2020

  As the election nears and a potential change in power of both the White House and Congress approaches, it is important to understand that significant healthcare policy can still be accomplished this year.

• Democratic And Republican Health Priorities In The Next Administration

  9/9/2020

  With the conventions and a contentious summer behind them, both political parties are laying out their agendas for the next four years. What are the Democratic and Republican health priorities?

• Trump Threatens Rx Industry With Executive Orders

  8/11/2020

  As Trump’s one-month deadline for a deal with PhRMA ticks away, nervous pharmaceutical executives are equally dismissive and anxious about the next actions of an often-impulsive president.

• Democratic House Passes Rx Price Controls Amid Pandemic

  7/10/2020

  During this COVID-19 crisis, government should be collaborating closely with industry to promote innovation that will save lives, improve health and bring back prosperity that can come with safely reopening the economy. Yet, it is astonishing that House Democrats have chosen the opposite path.

• More Nuanced Approach Needed To Fight COVID-19

  5/29/2020

  When will COVID-based decisions by politicians be guided by mounting data that suggests targeted approaches to containing the pandemic would be beneficial for both the vulnerable and the rest of the population, which must get on living their lives and providing for their families.

• Assisting Millions Of Uninsured Bogged Down In Abortion Politics

  5/11/2020

  Controversies over COBRA and abortion coupled with a decline in elective medical procedures plague the healthcare system during this COVID-19 crisis. 

• $2 Trillion CARES Act Attempts To Keep Health System Afloat

  4/6/2020

  Just weeks ago, America had the lowest unemployment rate in history, the stock market was setting record highs, and the political system had become so poisoned that the speaker of the House and the president, fresh off the Senate acquittal of impeachment articles, were not speaking to each other. That seems like a  dream that was eons ago.

• “Surprise Medical Bills” May Displace Rx Drugs As Healthcare Focus In 2020

  3/2/2020

  The same politics that fuel patient ire at the drug industry for rising out-of-pocket costs manifest in the other major focus of health legislation this year: “surprise medical bills,” which occur when a patient receives care from an out-of-network healthcare provider.

• Impeachment Halts Health Policy Advancement As Coronavirus Spreads

  2/7/2020

  As the impeachment trial of President Donald Trump dragged into the latter half of the second week, the wheels of healthcare policy development have ground to a halt.

• The Bipartisan Dismemberment Of The ACA

  1/10/2020

  Hours after the House of Representatives impeached President Donald J. Trump, it passed a gargantuan omnibus appropriation package costing $1.4 trillion in 2020 that continues the bipartisan unravelling of the Affordable Care Act (i.e., Obamacare) by repealing three taxes critical to its financing: the “Cadillac tax” on high-cost insurance plans, the medical device excise tax, and the health insurance tax. Together, their repeal costs the federal government $373.3 billion in lost revenue over the next 10 years according to the Joint Committee on Taxation.