CORONAVIRUS WORRIES CONTINUE AFTER EMERGENCY FUNDING BILL

Congressional approval last week of emergency spending to address the coronavirus hasn’t allayed Capitol Hill’s concerns about preparedness and response as the impact of the virus in the United States rapidly escalates.

Two lawmakers – Sen. Ted Cruz, R-Texas, and Rep. Paul Gosar, R-Ariz. – announced this weekend that after interacting with an individual last week who later tested positive for COVID-19, they were taking precautionary measures and would not be in Washington this week. The No. 3 elected House Republican, Rep. Liz Cheney, R-Wyo., was absent from a GOP retreat in Maryland this weekend because she wanted to limit participation in nonessential gatherings.

President Donald Trump on Friday signed legislation providing $8.3 billion to fight the outbreak, primarily through the Department of Health & Human Services.

Democrats have been sharply critical of the Trump administration’s response to the threat. Last week, 60 House Democrats sent a letter to Trump calling the response “dangerously inadequate” and “frankly frightening.” They focused their criticism on the disparate statements coming from cabinet officials and an unclear chain of command, which they believe show a lack of a coherent strategy.

Sen. Patty Murray, D-Wash., the top Democrat on the Health, Education, Labor, and Pensions Committee, sent a letter to Vice President Mike Pence criticizing the administration’s rollout of tests for the virus.

Lawmakers in both parties have expressed concern about medical product shortages, and they are responding legislatively. A bipartisan group of House members last week introduced legislation to enhance the Food and Drug Administration’s (FDA) ability to enforce transparency in the drug supply chain. A separate House group introduced a bill to require medical device manufacturers to report an expected shortage of critical technologies, which is currently required of drugmakers.

FDA, CDC HEADS FACE APPROPRIATORS

Trump administration health officials will be on Capitol Hill this week to testify about their agencies’ proposed fiscal 2021 budgets, but they are expected to be sharply questioned on the administration’s response to the coronavirus.

Dr. Robert Redfield, the director of the Centers for Disease Control and Prevention (CDC), and Dr. Stephen Hahn, administrator of the FDA, will both appear Tuesday before the House subcommittee that funds most of the federal government’s healthcare budget.

Redfield and Hahn have been two of the key faces of the Trump administration’s initial coronavirus response. Redfield is likely to face questions about the CDC’s approach to approving kits to test for the virus, while Hahn will be questioned about the development of a coronavirus vaccine. Hahn also is likely to face questions about potential prescription drug and device shortages, a growing concern for lawmakers.

Democrats also will press Hahn on the issue of affordability of a coronavirus vaccine and, likely, of pharmaceuticals in general.

HOUSE DEMOCRAT TO INTRODUCE ORPHAN DRUG TAX CUT

While the pharmaceutical industry has come under criticism from congressional Democrats for the prices of prescription drugs targeting rare diseases, one Democrat wants to give the industry a bigger tax break to incentivize the development of more treatments for rare conditions.

Rep. Josh Gottheimer, D-N.J., said he plans to introduce legislation later this month to reinstate a higher deduction for the Orphan Drug Tax Credit. Congress in 2017 reduced the tax credit for rare disease clinical trial expenses from 50% to 25%. The move saved the government $32.5 billion over 10 years.

Rare diseases are those affecting fewer than 200,000 people in the United States

Nearly 30 million Americans suffer from a rare disease or condition, but only 4% of those diseases have an approved treatment, according to the industry trade association BIO. Still, the tax credit has stimulated investment in new treatments. Since the tax credit was enacted in 1983, the Food and Drug Administration has approved 486 orphan products and more than 200 new orphan drugs.

COMMITTEE LEADERS WANT INFORMATION ON DRUG MARKET WITHDRAWALS

The bipartisan leadership of the House Energy and Commerce Committee is pressing the FDA on requirements of pharmaceutical manufacturers to report on the market status of their products.

The lawmakers are focused on implementation of reporting requirements they included in the most recent FDA user fee reauthorization. The law included various provisions aimed at enhancing generic competition in the pharmaceutical market as well as enhancing transparency around generics’ marketing status to ensure clarity about whether generic competition exists.

The lawmakers’ letter to the agency specifically addresses ways that generic manufacturers may manipulate the market, in light of a price-fixing scheme alleged by 44 states in a 2019 lawsuit.

At the same time, the lawmakers acknowledge legitimate reasons that companies may choose to enter and leave certain markets. They are seeking a briefing from FDA officials on how the agency monitors marketing status information and any further action that might be needed.

The letter is signed by Reps. Frank Pallone, D-N.J., and Greg Walden, R-Ore., the leaders of the full committee; Health Subcommittee leaders Anna Eshoo, D-Calif., and Mike Burgess, R-Texas; and Oversight Subcommittee leaders Diana DeGette, D-Colo., and Brett Guthrie, R-Ky.

KIDNEY CAUCUS TO HOST BRIEFING ON FUTURE OF KIDNEY CARE

The Congressional Kidney Caucus will host a briefing Thursday on Capitol Hill titled “The Future of Kidney Care in America.”

Caucus chairs Suzan DelBene, D-Wash., and Larry Bucshon, R-Ind., will host the briefing along with advocacy groups Kidney Care Partners and the National Kidney Foundation. Officials from the U.S. Department of Health & Human Services, National Institute of Diabetes and Digestive and Kidney Diseases, and Cleveland Clinic also plan to speak.

The briefing will highlight developments in care, policies and shared priorities to improve quality, access and choice for individuals living with kidney disease, kidney failure and transplants. Speakers will also discuss the Trump administration’s Advancing American Kidney Health initiative as well as efforts on Capitol Hill to improve kidney care.

BLACK MATERNAL HEALTH CAUCUS TO ROLL OUT ‘MOMNIBUS’

Reps. Alma Adams, D-N.C., and Lauren Underwood, D-Ill., and Sen. Kamala Harris, D-Calif., will join colleagues in the Black Maternal Health Caucus on Tuesday to announce a legislative package addressing maternal health.

The caucus is set to unveil a series of nine bills they are calling the “Black Maternal Health Momnibus,” a play on the “omnibus” spending packages Congress approves.

The “momnibus” legislation would build on existing maternal health measures to fill gaps in an effort to comprehensively address what the lawmakers say is an “urgent maternal health crisis.” They also hope to close racial disparities in outcomes, they said.

Adams and Underwood have been leaders in raising awareness of maternal health problems, including launching the caucus last year.