CONGRESS SPEEDS TOWARD EMERGENCY CORONAVIRUS FUNDING PACKAGE

As novel coronavirus continues to sweep the globe, Congress and the White House are assembling a spending package with billions in emergency spending and new authorities to combat the crisis.

Leaders hope to reach an agreement by as soon as this afternoon, which procedurally would allow the House to vote Wednesday and the Senate to approve it before the end of the week.

House and Senate appropriators worked through the weekend to provide billions to the Health and Human Services Department (HHS) and the State Department to help fight the global outbreak and limit its spread in the United States.

Funding levels emerged early as a flashpoint between the Trump administration and Democrats on Capitol Hill. The administration requested $2.5 billion – a figure Democrats quickly panned as insufficient.

Another possible flashpoint in the emergency legislation is language backed by House Democrats on prescription drug pricing. Democrats had at first proposed codifying “march in” rights to force licensing for potential treatments the government deemed too costly. Democrats were said to be backing off that provision amid opposition from Senate Republicans and the White House. But Democrats were still insisting on another regime to ensure manufacturers don’t engage in what they called “price gouging.”

Rep. Jan Schakowsky, D-Ill., a vocal critic of the pharmaceutical industry, last week led 45 of her Democratic colleagues in writing to the administration in opposition to giving private companies exclusive licenses and “authority to set prices and determine distribution.” House Speaker Nancy Pelosi, D-Calif., and Senate Democratic Leader Sen. Chuck Schumer, D-N.Y., also said any coronavirus bill must ensure that “vaccines are affordable and available to all that need it.”

The industry is concerned that any pricing provisions in the bill could be a “camel’s nose” that could lead to broader efforts to control prices. Congressional Republicans and HHS Secretary Alex Azar also say vaccines should be affordable, but caution against using the emergency legislation to set prices or place other limits on the private sector’s participation.

Meanwhile, in addition to the funding activity, coronavirus is dominating the congressional hearing schedule, with no fewer than six committees holding hearings in the House and Senate this week.

HEALTH PANEL TO CONTINUE RESPONSE TO DRUG ABUSE

The House Energy and Commerce Health Subcommittee will hold a legislative hearing Tuesday to review more than a dozen bills to address drug abuse.

Congress in recent years has approved comprehensive legislation providing billions of dollars and giving new authority to federal and state officials to combat opioid abuse and treat overdose victims. Yet lawmakers continue to hear of the toll of widespread drug abuse – including the emerging growth of cocaine and methamphetamine use, as full committee Chairman Frank Pallone, D-N.J., and subcommittee Chairwoman Anna Eshoo, D-Calif., noted in announcing this week’s hearing.

Lawmakers’ interest in looking beyond opioid abuse has grown recently. At the beginning of this year, the bipartisan leadership of the Energy and Commerce Committee noted the rise of cocaine and methamphetamine use and sought an update from the administration.

The committee on Tuesday will review a series of bills, including to expand medical training in addiction and pain management, clarify requirements on drug distributors in reporting suspicious orders, expand support programs for families facing addiction, and ensure Medicaid coverage for individuals as they are released from incarceration, among other measures.

LAWMAKERS TO INTRODUCE DIAGNOSTIC TEST REGULATION BILL

Bipartisan legislation to comprehensively address regulation of diagnostic tests will likely be introduced in the House and Senate this month.

Reps. Diana DeGette, D-Colo., and Larry Bucshon, R-Ind., and Sens. Richard Burr, R-N.C., and Michael Bennet, D-Colo., will introduce the bills, which would build on a discussion draft circulated in late 2018.

The issue has for years been a subject of intense debate among clinical labs, diagnostic test manufacturers, and the Food and Drug Administration (FDA). Current law gives the Centers for Medicare and Medicaid Services some authority over lab-developed tests, while FDA regulates diagnostic tests as medical devices. The overhaul would create a new category called “in vitro clinical tests” that would capture both diagnostic tests and lab-developed tests and provide a regulatory framework through the FDA – a move then-Commissioner Scott Gottlieb called for in 2018.

The legislative sponsors have gathered input from stakeholders since the introduction of the discussion draft in late 2018, and also needed to bring Burr onboard to replace retired Sen. Orrin Hatch, R-Utah, the former chairman of the Senate Finance Committee.

Indeed, the Trump administration is now facing increasing scrutiny over the botched rollout and possible contamination of coronavirus test kits from the Centers for Disease Control and Prevention.

HOUSE APPROPRIATORS TO REVIEW NATIONAL INSTITUTES OF HEALTH BUDGET

As the annual congressional appropriations process chugs forward, the House Appropriations subcommittee that funds HHS this week will review the Trump administration’s fiscal 2021 budget request for the National Institutes of Health (NIH).

NIH Director Francis Collins is scheduled to appear Wednesday before the subcommittee, as are five directors of various institutes including Dr. Anthony Fauci of the National Institute of Allergy and Infectious Diseases. Fauci is a key figure in the administration’s coronavirus response, especially in the development of a vaccine. He also was one of several officials to participate in a Friday update for House members on the virus.

In addition to the coronavirus response, the institutes’ role in drug development is likely to be a key flashpoint in the hearing. In addressing concerns over prescription costs, many Democrats have sought to portray government agencies like NIH doing most of the research and pharmaceutical companies reaping most of the profits on prescription drugs – a narrative that Republicans and most stakeholders sharply push back against.

Indeed, even Fauci last week lauded the partnership between NIH and industry as a “natural process” and noted that even when government researchers do substantial research work, products cannot be “brought to the goal line without a partnership with industry.”

One area of bipartisan agreement is criticism of the administration’s proposed cuts to NIH in the budget that the subcommittee will review. Subcommittee Chairwoman Rosa DeLauro, D-Conn., and ranking Republican Tom Cole, R-Okla., are vocal supporters of NIH research and blasted the proposed cuts last week with HHS Secretary Alex Azar.

Azar faced similar criticism from Senate appropriators, including DeLauro’s Senate counterpart, Subcommittee Chairman Roy Blunt, R-Mo., also a strong supporter of NIH funding, who told Azar that he “will never write a bill that slashes the investment in medical research.”