HEALTH CARE BRIEFING: Foreign Drug Reliance Won’t Wane, FDA Says

The coronavirus won’t be the last time that the U.S. grapples with a pandemic, so it should shore up its domestic drug manufacturing capacity now, an FDA official told lawmakers yesterday.

The U.S. is heavily reliant on drug manufacturing in India and China, making the supply chain vulnerable during global disease outbreaks. Drug companies could move more production back to the U.S. using advanced—albeit more expensive—manufacturing techniques that hasten production and reduce environmental impacts more than traditional production measures.

Congress must encourage companies to invest in the updated manufacturing processes in the U.S. before the next pandemic strikes, Douglas Throckmorton, deputy director for regulatory programs at the FDA Center for Drug Evaluation and Research, told the Senate Finance Committee.

“Covid-19 won’t be the last time that we’re asked to respond to an emergency of this size,” Throckmorton said.

Reliance on foreign drug manufacturing is a sign the U.S. should be shoring up domestic manufacturing, Sen. John Cornyn (R-Texas) said.

The Senate hearing comes after the Food and Drug Administration announced it would halt its inspections of overseas drug manufacturing due to the pandemic. The agency said in mid-May it was still “postponing domestic and foreign routine surveillance inspections.” Read more from Jacquie Lee.

Also in Virus Efforts on the Hill

Lawyer Confirmed to Be Virus Spending Watchdog: The Senate confirmed White House lawyer Brian Miller to be the federal watchdog overseeing trillions of dollars in loans and grants being provided to boost the U.S. economy reeling from the global pandemic. As special inspector general for pandemic recovery, Miller will lead oversight of money going from the Treasury Department and Federal Reserve to airlines, national security companies and other companies seeking low-interest loans.

Miller, who was confirmed on a 51-40 vote, served as a White House lawyer and participated in Trump’s impeachment defense. He’s said he won’t be influenced by his former boss, who has demoted or removed several inspectors general whose work the president didn’t like. Read more from Laura Davison.

GOP Grills Whitmer in Hearing on State Responses: Michigan Gov. Gretchen Whitmer (D), a potential running mate for presumptive Democratic presidential nominee Joe Biden, took sharp questioning from Republicans yesterday during a House hearing on governors’ responses to the pandemic. Republicans blasted Whitmer, a first-term Democrat, saying she allowed elderly patients infected by the coronavirus to return to nursing homes.

“With all due respect I will not go toe to toe with you on every allegation you have alleged,” she responded when House Energy and Commerce Committee member David McKinley (R-W.Va.) pressed her on Michigan’s virus efforts. The virus “doesn’t stop at the state line and doesn’t stop at party line.” Read more from Alex Ebert.

Giroir Resignation Said to Hurt Testing Efforts: Senate Health, Education, Labor, and Pensions ranking member Patty Murray (D-Wash.), following the announcement that HHS Assistant Secretary Brett Giroir will be stepping down as the Trump administration’s “czar” for Covid-19 testing, said the White House still does not have a satisfactory testing strategy in place. “Now is not the time to dismantle federal leadership,” she said in a statement.

Research, Treatment & Coordination

Concerns Raised Over Covid-19 Study Data: Two prestigious medical journals said they have significant concerns about a database that was used to look at how older drugs, including an antimalarial drug promoted by Trump, may work in the treatment of Covid-19.

The New England Journal of Medicine yesterday published an “expression of concern” about a study published by the journal on May 1 that looked at the use of heart drugs called ACE inhibitors in coronavirus patients. Later in the day, the Lancet, a nearly 200-year-old U.K. medical journal, issued its own warning about a May 22 study about treating Covid-19 patients with hydroxychloroquine, the anti-malaria drug.

Both studies relied on data from a firm called Surgisphere, which says that it aggregates information from medical records around the globe. Last week, more more than 200 scientists signed a letter to the Lancet asking for greater transparency regarding the hospitals where patients’ medical records came from and the method of analysis, along with other issues. Read more from John Lauerman.

NIH Bringing Back Non-Covid-19 Research: The National Institutes of Health is in the early stage of physically bringing back staff who work on matters that are not related to Covid-19 research, NIH Office of AIDS Research Director Maureen Goodenow said yesterday at a meeting on the President’s Advisory Council on HIV/AIDS. The NIH’s clinical centers and research labs will have limited in-person staffing. The infrastructure for HIV clinical trials has been used for the outbreak, Goodenow said. Read more from Shira Stein.

Hospitals, Health Providers Get $250 Million to Combat Virus: Hospitals and other health-care providers will use a $250 million grant from the CARES Act to provide workforce training, expand telemedicine offerings, and purchase protective gear and equipment to help fight Covid-19. HHS has now provided $350 million to health-care systems during the pandemic through the March-passed coronavirus relief package. The latest round of funding, announced yesterday, will also support efforts to boost the nation’s capacity and capability to respond to and treat highly infectious diseases. Read more from Tony Pugh.

More Headlines:

• U.S. Confirmed Cases Rise 1.2%, in Line With Past Week’s Average
• CDC, OSHA Give Agriculture Workers Virus Protection Guidance
• Union Case for OSHA Emergency Virus Standard Moves Forward
• Trump Told Modi U.S. to Ship 100 Ventilators to India Next Week
• Trump, Bolsonaro Discussed Virus, Hydroxychloroquine Delivery
• Tokyo Issues Covid-19 Alert to Residents After New Cases Spike
• Spy Agencies Launch Rapid Search for Covid-19 Tech Tools
• Colleges Ask for Tax Credit to Offset Paid Sick-Leave Mandate

What Else to Know Today

CBP Separated Nearly 10 Times More Asylum-Seeking Families than Reported: Instead of seven, the U.S. Customs and Border Protection separated at least 60 asylum-seeking parents from their children at ports of entry in May and June of 2018, and possibly more but the data is still too unreliable to tell, a new government watchdog report finds. Some of the separated children were as young as 5 months old, Shaun Courtney reports.

The Department of Homeland Security Inspector General faulted CBP Office of Field Operations for its poor record keeping which continues to plague the agency, according to the report.

“We continue to have concerns about DHS’ ability to accurately identify and address all family separations due to data reliability issues,” the report states. “As a result, OFO may have separated more families before June 2018 than those we could identify.”

Kentucky Abortion Restriction Blocked: Kentucky can’t enforce a state law that would require women to induce fetal demise before undergoing a dilation and evacuation—the most common kind of second trimester abortion—after the Sixth Circuit found the statute unconstitutional. The law unduly burdens an individual’s right to elect to have an abortion prior to viability, the U.S. Court of Appeals for the Sixth Circuit said yesterday.

Several other states—including Alabama, Arkansas, Indiana, Kansas, Oklahoma, Louisiana, and Mississippi—have passed similar laws, and in every challenge brought to date, courts have enjoined the statutes on the same basis, the court said. Read more from Peter Hayes.

More Headlines:

• Reynolds Units Challenge Los Angeles Ban on Flavored Tobacco
• Acadia Investor Suit Trimmed But Safety, Kickback Claims Proceed

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; Zachary Sherwood at zsherwood@bgov.com; Michaela Ross at mross@bgov.com