HEALTH CARE BRIEFING: Biden Pressed on Drug Trafficking Response

A bipartisan group of senators is renewing a push to permanently ban highly addictive fentanyl analogs but are waiting for the Biden administration to weigh in first.

The rise in overdose deaths in the U.S. is partly driven by the presence of fentanyl, a synthetic opioid that can be made in various ways, Sens. Chuck Grassley (R-Iowa) and Maggie Hassan (D-N.H.) said. The pair want to empower the federal government to classify fentanyl-like drugs among the most-controlled substances.

“Fentanyl analogs are driving up the death toll,” Grassley said yesterday at a hearing of the Senate Caucus on International Narcotics Control. The two senators’ call for enshrining enforcement powers against traffickers reflects growing pressure on Biden’s administration to crack down on illegal trade and curb overdose deaths.

Earlier this year, Congress extended the government’s power to ban fentanyl-like substances until the end of October. Some lawmakers wanted these authorities to expire, arguing that they contribute to over-policing of people struggling with addiction.

The Biden administration asked lawmakers in April to extend the authority temporarily, to allow time to outline a comprehensive approach to dealing with drug trafficking and scheduling fentanyl substances—adding drugs to the list of banned substances.

Regina LaBelle, acting head of the Office of National Drug Control Policy, said yesterday her office will have a recommendation for lawmakers on whether to extend the authorities before they expire in October. “We are grateful that Congress extended the temporary scheduling earlier this year, as it’s given us an opportunity to develop a consensus approach,” she said. Read more from Alex Ruoff.

Happening on the Hill

Energy & Commerce Markup: The House Energy and Commerce Committee is scheduled to mark up 16 health bills including:

• H.R. 2379, to reauthorize and expand a grant program for state response to the opioid use disorders crisis;
• H.R. 2364, to provide for a public education campaign to raise public awareness of synthetic opioids;
• H.R. 2355, to facilitate responsible, informed dispensing of controlled substances and other prescribed medications;
• H.R. 951, to carry out a national campaign to increase awareness of the importance of maternal vaccinations for the health of pregnant and postpartum individuals and their children;
• H.R. 3742, to issue revised regulations to require the dissemination of information on Advisory Committee on Immunization Practices recommended immunizations to staff of nursing facilities; and
• H.R. 2347, to ensure adequate access to vaccines under the Medicaid program and the Vaccines for Children program.

Hearings on the Hill:

• Life Expectancy Disparities: The Senate Health, Education, Labor and Pensions Subcommittee on Primary Health and Retirement Security holds a hearing on disparities in life expectancy.
• Extreme Heat: The House Science, Space and Technology Environment Subcommittee holds a hearing on extreme heat in the U.S.

Clyburn Probes Pandemic Evictions: House Majority Whip James Clyburn (D-S.C.), who leads the Select Subcommittee on the Coronavirus Crisis, is requesting documents from four corporate landlords with “high eviction rates” during the Covid-19 pandemic. The companies, Invitation Homes, Pretium Partners, Ventron Management, and the Siegel Group, filed for over 5,000 evictions during the crisis, according to a statement.

Pandemic Preparedness Bill Advances: House lawmakers advanced a bill aimed at ending shortages in domestic personal protective equipment supply chains to prepare for future pandemics. The House Committee on Oversight and Reform approved H.R. 4470 by a unanimous vote yesterday. Its next stop is the House floor. Read more from Allie Reed.

Senators Seek Updates on Health-Care Antitrust: Sens. Patrick Leahy (D-Vt.) and Steve Daines (R-Mont.) yesterday requested updates from the Federal Trade Commission and Justice Department on their efforts to combat anti-competitive conduct in the health insurance sector, according to a statement. The letter comes after the enactment of the Competitive Health Insurance Reform Act in January of this year.

• Meanwhile, companies’ reporting requirements for startup acquisitions are poised for an overhaul as the FTC considers reviving a decades old policy on deals rife with future competition implications. Restoring pre-1995 reporting requirements could particularly impact the pharmaceutical community, said Jeny Maier, an attorney in Axinn, Veltrop & Harkrider LLP’s antitrust group. Read more from Siri Bulusu.

Delta Is 83% of Cases, Walensky Tells Senators: The delta variant makes up 83% of all sequenced Covid-19 cases in the U.S., CDC Director Rochelle Walensky told a Senate panel yesterday. The new figure was a major increase from 50% the week of July 3, she said. Regions in the U.S. with low vaccination coverage are allowing faster spread of the highly transmissible variant, first identified in India. Fiona Rutherford has more.

• Also at the hearing, several Republicans pressed health officials to allow Covid-19 vaccine booster shots for vulnerable populations, such as cancer patients, based on data from Israel and other countries. The heads of the CDC and FDA said they’re constantly monitoring what’s happening in the U.S. and around the world but don’t have enough data to support recommending boosters. Jeannie Baumann has more.

Remote Voting Survives GOP Challenge: A Republican-led challenge to a resolution permitting members of the House to vote remotely during the pandemic fell flat yesterday after the D.C. Circuit said the change can’t be reviewed in court. The proxy voting resolution, adopted in May 2020, deals with “core legislative acts,” and thus is covered by the Constitution, the U.S. Court of Appeals for the D.C. Circuit ruled. Jacklyn Wille has more.

Cyber Breach Reporting Mandated in Bill: Federal agencies and critical infrastructure operators such as energy companies and hospitals would have to report cyber intrusions within 24 hours to the Department of Homeland Security or face penalties, under a bipartisan bill unveiled today. Read more from Rebecca Kern.

The Coronavirus Pandemic

End of Health Crisis Will Put Covid-19 Products in Limbo: Covid-19 vaccines, therapies, and other related products are available in the U.S. thanks to more than 400 emergency use authorizations granted by the FDA during the pandemic.

Nearly all of those products are at risk of being taken off the market once the declaration for the public health emergency ends—unless and until they attain full approval. The Food and Drug Administration has been working on guidance for almost a year on how to transition from emergency status, but businesses need to start preparing now, attorneys say. Read more from Jeannie Baumann.

Pelosi Aide, White House Official Test Positive: A senior spokesperson for Speaker Nancy Pelosi (D-Calif.) and a White House official—both fully vaccinated—have tested positive for Covid-19. The Pelosi staffer had no contact with the speaker since being exposed, a spokesperson said in a statement yesterday. And a White House official said the infected aide didn’t have close contact with senior people. Billy House and Jordan Fabian have more.

Report Says Shows Test Price Gouging Evidence: A new report from the trade group America’s Health Insurance Plans says price gouging for Covid-19 tests remains an issue, with the average commercial market test costing $130 and data showing “the share of tests charging 50% to 100% above the average cost has doubled” since earlier in the pandemic, according to a press release.

More on the Pandemic:

• U.K. Reopening in Chaos as Ministers Undermine Isolation Orders
• More Companies Pull Out From Tokyo Games’ Opening Ceremony
• Singapore Curbs Gatherings, Eyes Additional Economic Assistance
• Half of Australia Back in Lockdown, as Delta Variant Tests Strategy
• Secretive Body Is Making Questionable Covid-19 Decisions in India
• Vaccine, Ventilator Shortages Show a Need for Free Trade in Africa
• Covid-19 Takes Dramatic Toll on U.S. Life Expectancy
• More Variants Are Coming, and the U.S. Isn’t Ready to Track Them

What Else to Know Today

Cancer Doctors Ask Biden, Congress to Reject Medicare Cuts: The radiation oncology community is calling on President Joe Biden and Congress to stop proposed Medicare pay cuts and policy changes that they say could jeopardize access to care for cancer patients. Radiation oncologists face a 5% pay cut in 2022 under the proposed Medicare physician fee schedule (RIN 0938-AU42). Read more from Tony Pugh.

Cigar Industry Rebuffed on FDA Fees: The FDA properly implemented federal law in extended some rules for cigarettes to other tobacco products, and when it levied fees on cigars and pipe tobacco, the D.C. Circuit said yesterday in a defeat for the cigar industry. The FDA didn’t act arbitrarily when it set fees for cigars but not e-cigarettes because Congress said fees should apply to only six types of products, the court said. Read more from Martina Barash.

More Industry Headlines:

• SmileDirectClub Wins Major Fight in Its War Against Dental Boards
• Glaukos, Inspire Medical Sink Again After Medicare Payment Rules
• NeuroMetrix Soars 208% After Reporting FDA Breakthrough Status
• Lumos Pharma Drops Postmarket After Trial Timelines Stretch Out

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

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