trending Market Intelligence /marketintelligence/en/news-insights/trending/yYQLcvatgzy4EBLoOleQUg2 content esgSubNav
In This List

Clock is ticking on drug pricing bills, Trump's health plan, US FDA nominee

Blog

A Pharmaceutical Company Capitalizes on M&A Activity with Brokerage Research

Blog

2021 Year in Review: Highlighting Key Investment Banking Trends

Blog

Insight Weekly: US stock performance; banks' M&A risk; COVID-19 vaccine makers' earnings

Blog

Global M&A By the Numbers: Q3 2021


Clock is ticking on drug pricing bills, Trump's health plan, US FDA nominee

Congress has returned to Capitol Hill after its monthlong recess and faces a jam-packed legislative to-do list, including finishing its efforts to lower Americans' prescription drug costs and end surprise medical bills.

SNL ImagePeace Monument statue at the U.S. Capitol
Source: Associated Press

The Senate's finance, judiciary and health panels all advanced bills to the chamber's floor, but those must be reconciled into one package before senators can take a vote.

The House has adopted some drug pricing measures, but Speaker Nancy Pelosi, D-Calif., is expected to unveil a broader package this month for her chamber to consider.

But progress on the drug pricing and medical bills legislation is expected to be sidelined until Congress finishes its work on funding the federal government for fiscal 2020 an action it must take before Oct. 1 to avoid another government shutdown.

With the Senate lagging far behind the House, Congress is expected to adopt a short-term funding measure.

According to the Bipartisan Policy Center, in the first six months of the current Congress, most of the indicators about the quality of the legislative process were negative — an outcome that bodes poorly for the pending drug prices and surprise medical bills legislation.

Trump's healthcare plan

President Donald Trump is also due to unveil his healthcare plan during a speech this month, according to White House Counselor Kellyanne Conway.

Trump's plan, however, will not be a replacement of the Affordable Care Act, Conway told reporters on Aug. 7.

During a July 23 speech, Health and Human Services Secretary Alex Azar said Trump would "protect what works and fix what's broken" for "all 330 million Americans."

But Azar did not provide details about how Trump would achieve that goal. The HHS secretary also criticized Democratic proposals for a single-payer system or adding a public option, calling those ideas a "government takeover" of healthcare.

SNL ImageHHS Sec. Alex Azar
Source: Associated Press

More than half of House Democrats now support a single-payer bill from Reps. Pramila Jayapal, D-Wash., and Debbie Dingell, D-Mich., though Pelosi has shunned the measure.

During an Aug. 15 briefing with reporters, Centers for Medicare and Medicaid Services Administrator Seema Verma acknowledged Trump will likely only lay out a set of principles in his speech and leave the work to Congress of figuring out how to implement those ideas.

A number of administration officials, including Trump, have said they want to keep key provisions of the ACA in place, like the 2010 law's protections for patients with preexisting medical conditions, CMS' Center for Medicare and Medicaid Innovation and the U.S. Food and Drug Administration's pathway for approving lower-cost biologic therapies, or biosimilars.

But no one in the Trump administration has identified key measures from the ACA they want nixed.

In his July 23 speech, Azar vowed the administration would "always protect Americans with preexisting conditions — a guarantee we will maintain at the federal level."

But that promise conflicts with the administration's extension of short-term health plans, many of which do not guarantee preexisting conditions protections.

Meanwhile, the U.S. Court of Appeals for the 5th Circuit is set to soon rule on whether to uphold a Texas district judge's December 2018 decision that the ACA is unconstitutional — an action that could leave millions of Americans without healthcare coverage.

Trump must act on FDA nomination

Also on Trump's plate is the decision about who he will nominate to permanently lead the FDA — a choice he must make by early November, when the 210-day time limit runs out for Acting Commissioner Ned Sharpless to serve.

SNL ImageStephen Hahn
Source: MD Anderson Cancer Center

For now, Stephen Hahn, chief medical executive at MD Anderson Cancer Center in Houston, is Sharpless' top competition.

Hahn would be walking away from a $1.3 million a year job if he is selected for the FDA position, which pays just over $155,000 annually. He was also rumored to be under consideration as the physician-in-chief at Memorial Sloan Kettering Cancer Center — a job that pays about double what Hahn is making now at MD Anderson.

Hahn has no regulatory or industry background. His only government experience was six years from 1989 to 1995 in the U.S. Public Health Service at the National Cancer Institute.

Sharpless previously led the NCI and has the backing of five former FDA commissioners and nearly 60 healthcare organizations.

But he also has been facing criticism from some lawmakers, particularly Senate Democratic Whip Dick Durbin of Illinois, who late last week called for Sharpless to take decisive action within 10 days on regulating e-cigarettes or resign. The products have been tied to 450 respiratory illnesses and at least three deaths.