HEALTH CARE BRIEFING: Panel Scrutinizes Quick FDA Drug Approvals


By Brandon Lee

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A House committee will spotlight an FDA process that’s been criticized as putting some of the costliest drugs on the market with limited evidence.

The House Energy and Commerce Committee Health Subcommittee will tackle 22 pieces of legislation at a hearing on Thursday about the future of medicine. The hearing comes as the Congress considers legislation to reauthorize user fees, which the Food and Drug Administration takes from drug and device-makers to fund its operations. The current five-year authorization expires Sept. 30, and the hearing is the first stop for some of these bills to wind up as riders on that must-pass user fee package.

Not all of the 22 bills will make it across the finish line. The hearing “will help them in their process in identifying which ones have the appropriate support to be able to be incorporated into at least the initial draft of the user fee bill,” Jeff Allen, CEO of Friends of Cancer Research, said in an interview.

Allen is one of five witnesses that will testify at the hearing, which also includes representatives from the two brand-name drug industry groups that negotiate the Prescription Drug User Fee Act with the FDA, and the trade group representing the generics industry.

Both House Energy and Commerce Chair Frank Pallone (D-N.J.) and Rep. Cathy McMorris Rodgers (R-Wash.), the committee’s ranking member, sponsored separate bills (H.R. 6963, H.R. 6996) to overhaul the FDA’s accelerated approval process. The agency’s controversial move to approve Biogen‘s Aduhelm to treat Alzheimer’s disease using accelerated approval thrust the fast-track process into the spotlight. Read more from Jeannie Baumann and Celine Castronuovo.

Biogen Lays Out Aduhelm Data in Obscure Journal: Biogen on Wednesday published the final efficacy results from two late-stage studies of its Alzheimer’s disease drug Aduhelm in a lesser-known medical journal, nine months after federal regulators cleared the treatment. Cambridge, Mass.-based Biogen was under pressure to divulge details from the trials, which ultimately produced conflicting results after being halted early. One study suggested that Aduhelm, which removes the plaque “amyloid” from the brain, could slow the onset of Alzheimer’s, while the other did not. Angelica Peebles and Robert Langreth have more.

Also Happening on the Hill

Progressives to Outline Executive Order Asks: The Congressional Progressive Caucus—Congress’s most-left leaning Democrats—are calling on the White House to use its authority to lower the cost of medicines like insulin and EpiPen through its contracting power and other authorities, Alex Ruoff reports.

The requests are part of a larger agenda to be released by the CPC today on executive orders the Biden administration can take to advance Democrats’ domestic agenda, stalled largely by party infighting and a tight majority in the Senate.

“We’re not abandoning legislation, but executive actions take a while,” Rep. Pamila Jayapal (D-Wash.), head of the CPC, said Wednesday. “We want to get these ideas out. Push on executive action, push on the legislation, push in every direction to make sure that we’re cutting costs for people.”

The executive order requests reflect demands Jayapal and other progressives have been making since the early days of the Biden administration, such as allowing drug manufacturers in other countries to make their own versions of Covid-19 vaccines and inserting language into government contracts for medical research that new medicines developed be reasonably priced.

Democrats Move to Break Drug Price Impasse: Senate Democrats are also trying to put new energy into their long-time goal of empowering the government to demand lower drug prices, but face the same hurdles that stalled President Joe Biden’s domestic spending measure. Democrats want the government to negotiate with drug companies and place limits on what millions of Americans pay for certain drugs.

Finance Chairman Ron Wyden (D-Ore.) said he hopes to breathe new life into the drug-pricing proposal by focusing on the benefits of lower prescription costs for Americans. He said he wants to bring “urgency” to changes he and other Democrats have urged for years.

Wyden told reporters Tuesday he speaks regularly with Sen. Joe Manchin (D-W.Va.), whose opposition to the House-passed Build Back Better Act (H.R. 5376) has kept it from becoming law. He said the key to uniting his caucus is focusing on areas where they agree and that cut household costs for Americans, namely drug costs. Manchin has recently emphasized he’d vote for a narrower bill than the Build Back Better Act focused on fighting inflation. He said he supports the drug-pricing portions of the package, but on Tuesday told reporters he hasn’t seen a broad proposal he could vote for. Read more from Alex Ruoff.

Warren Says Drugmakers Give Misleading Price Info: A group of Democrats led by Sen. Elizabeth Warren (D-Mass.) sent a letter to the CEO of the Pharmaceutical Research and Manufacturers of America after receiving “an inadequate response” to their first inquiry, according to a statement Wednesday. “Your letter was simply unresponsive to our concerns, leading to one clear conclusion: there is no good explanation for drug manufacturers’ behavior other than corporate profiteering,” lawmakers, also including Sen. Amy Klobuchar (Minn.) and Rep. Jan Schakowsky (Ill.), wrote, Maria Luiza Rabello reports.

  • Meanwhile, Blue Cross and Blue Shield units and other health care plans allege that Walgreen engaged in a fraudulent scheme to overcharge for prescription drugs by submitting claims for payment at inflated prices and made false statements to conceal the scheme. Walgreens has overcharged the plaintiffs hundreds of millions of dollars, the plaintiffs said in a Tuesday complaint filed in the U.S. District Court for the Northern District of Illinois. Read more from Daniel Seiden.

Clinical Trial Diversity Draws Industry Resistance: The drug industry trade group wants Congress to back off from mandates meant to improve the diversity of clinical trial participants, even as it supports proposals to move these studies into community settings. The additional mandates “would have serious unintended consequences of reinforcing rather than overcoming known barriers to participation for patients,” a top Pharmaceutical Research and Manufacturers of America executive said in prepared remarks ahead of Thursday’s House Energy and Commerce health subcommittee hearing. Jeannie Baumann has more.

Senate Hearing Set on Mental Health Programs: Senate Health, Education, Labor, and Pensions Chairwoman Patty Murray (D-Wash.) announced the panel will hold a hearing on strengthening federal mental health and substance use disorder programs. Key federal officials for mental health issues are set to testify, including Miriam Delphin-Rittmon, assistant secretary of the Substance Abuse and Mental Health Services Administration; Carole Johnson, administrator of the Health Resources and Services Administration; and Joshua Gordon, head of the National Institute of Mental Health at the National Institutes of Health.

What Else to Know Today

What Europe’s Covid Trends Mean for U.S.: Covid cases are falling in the U.S. while vaccine and mask rules are being repealed. Yet over a third of the wastewater sample sites across the U.S. showed rising case levels in the first 10 days of March. So is Covid going away or not? For the experts, there are quite a few reasons to believe Americans shouldn’t let their guards down yet. “The world has decided Covid is over for some reason—and that really worries me,” said Akiko Iwasaki, a professor of immunobiology at Yale School of Medicine. “Lifting all of these mandates so quickly is asking for trouble.”

Throughout the pandemic, U.S. trends have largely trailed those in Europe by a few weeks. For most of the continent, infections are on the rise again after plunging from their winter omicron peaks. There are three main factors driving the jump, all of which could apply to the U.S., experts said. The first is that omicron’s dubious cousin, labeled “BA. 2,” is reportedly more transmissible than its predecessor. In Europe, it has quickly overtaken the initial omicron strain, and now accounts for the majority of cases in the U.K. This hasn’t happened in the U.S. just yet—but warning signs are beginning to surface. Read more from Madison Muller.

More Coronavirus Headlines:

FDA Resumes Foreign Inspections as Quality Concerns Resurface: The robustness of the FDA’s foreign inspections program will get a renewed focus as the agency resumes global surveillance activities following a pause due to the pandemic. The Food and Drug Administration resumed domestic surveillance inspections this year and plans to begin conducting foreign prioritized inspections in April. As the FDA addresses a two-year inspection backlog, attorneys say the agency should also use this moment to address repeated complaints with its foreign inspection practices. Read more from Celine Castronuovo.

S.C. Abortion Law Redo Request Backed by 21 States: An Alabama-led group of 21 states joined South Carolina in urging the full Fourth Circuit to rehear a case testing abortion providers’ ability to sue the state over a six-week limit on abortions. A three-judge panel that affirmed providers’ standing to sue should have permitted other provisions of the law to take effect, the states said in a friend of the court brief filed in the U.S. Court of Appeals for the Fourth Circuit. South Carolina’s law banned abortions after cardiac activity was detected, which occurs at about six weeks’ gestation. Read more from Mary Anne Pazanowski.

Firms Covering Abortion Travel Have One Thing in Common: Citigroup, Match Group and Bumble stand out among publicly traded companies for helping cover travel costs for their employees seeking abortions after several U.S. states implemented or proposed a near-total ban on the procedure. The firms also have something else in common: all have women as CEOs. Daniel Taub has more.

More Headlines:

To contact the reporter on this story: Brandon Lee in Washington at blee@bgov.com

To contact the editors responsible for this story: Giuseppe Macri at gmacri@bgov.com; Michaela Ross at mross@bgov.com

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