Senators Comment on Zika Vaccine Pricing

Six senators have written to the French drug company Sanofi to express concerns about the manufacturer’s refusal to commit to a reasonable licensing agreement for a Zika vaccine. The lawmakers state that they will urge the U.S. Army not to finalize any contracts with Sanofi until terms that will ensure an affordable price are met. The Army began a $43 million partnership with Sanofi last year to bring a vaccine to market, with the potential for Sanofi to earn an additional $130 million in funding. Separately, the senators have requested a public hearing on the acquisition of a Zika vaccine. The letter was signed by Sens. Dick Durbin (D-Ill.), Sherrod Brown (D-Ohio), Bernie Sanders (I-Vt.), Richard Blumenthal (D-Conn.), Ed Markey (D-Mass.), and Angus King (I-Maine).

Lawmakers Investigate NIH Research Protocol

Leadership of the House Energy and Commerce Committee are investigating a medical research protocol that allegedly does not align with the Food and Drug Administration’s (FDA) rules for informed consent. Chairman Greg Walden (R-Ore.) and Oversight and Investigations Subcommittee Chairman Tim Murphy (R-Pa.) have written to the National Institutes of Health (NIH) on behalf of a constituent whose now-deceased wife went into cardiac arrest, and was later considered a participant in the Resuscitation Outcomes Consortium (ROC), sponsored by the National Heart, Lung, and Blood Institute (NHLBI). The constituent learned that participants have to actively opt-out of the study. Because his wife was unconscious, she was automatically enrolled in the ROC. The lawmakers pose a number of questions about the NIH’s protocol, and ask for a response from NIH Director Francis Collins by July 18, 2017.

Trump Nominates New Surgeon General

President Trump has tapped Jerome Adams to be U.S. Surgeon General. Adams is an anesthesiologist and is currently serving as the health commissioner for the state of Indiana, a post he was appointed to in 2014 by now-Vice President Mike Pence. He has previously worked as a staff anesthesiologist and assistant professor of anesthesiology at the Indiana University School of Medicine. If confirmed, Dr. Adams would replace Rear Admiral Sylvia Trent-Adams, the current acting surgeon general, who took over the post after Vivek Murthy was dismissed by President Trump.

House Passes MLR Legislation

The House of Representatives passed legislation to overhaul the medical liability system last week. H.R. 1215, the Protecting Access to Care Act (PACA), was passed by a vote of 218-210, with 19 Republicans crossing the aisle to join all House Democrats to vote against the bill. PACA is considered a part of the GOP’s broader effort to repeal and replace Obamacare. The bill would limit damages and lawyers’ fees for cases related to federally subsidized health care. Medical malpractice awards for non-economic damages would be capped at $250,000 under the bill. The bill would also establish a three-year statute of limitations after an injury, or one year after the discovery of an injury. PACA would preempt state laws, except in cases where the state has already specified a shorter time period for the statute of limitations, or a particular amount of damages that can be awarded in a lawsuit. The Congressional Budget Office (CBO) estimates that the bill would reduce the deficit by $50 billion over the next decade. It is unclear whether the bill will advance in the Senate, where Democrats are opposed to the liability cap, and some Republicans have voiced concerns about infringing upon states’ rights. More than two-dozen states already have award caps in place. To respond to concerns related to state’ rights, the provisions in the PACA legislation are limited to when a medical liability case involves federal healthcare funds.

Drug Pricing Hearings to be Postponed

According to Stat News, Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Lamar Alexander (R-Tenn.) is suspending his panel’s investigation into the high cost of prescription drugs. He blames panel Democrats for the decision, citing their refusal to focus on the issue at hand during the first drug pricing hearing, and instead focusing on ongoing efforts to repeal and replace the Affordable Care Act (ACA). The second hearing in the drug pricing series was originally scheduled to take place this month with a third hearing planned for the fall.

E&C Health Advances Four Public Health Bills

The House Energy and Commerce Health Subcommittee marked up four pieces of public health legislation last week. H.R. 767, the Stop, Observe, Ask and Respond (SOAR) Act, authored by Rep. Steve Cohen (D-Tenn.), would set up a pilot project to identify and assist human trafficking victims. H.R. 880, the Military Injury Surgical Systems Integrated Operationally Nationwide to achieve ZERO Preventable Deaths (MISSION ZERO) Act, authored by Rep. Michael Burgess (R-Texas), would provide grants to trauma centers to help improve military surgical systems. H.R. 931, the Firefighter Cancer Registry Act, authored by Rep. Chris Collins (R-N.Y.), would require the Centers for Disease Control and Prevention (CDC) to develop a voluntary registry of firefighters and link the data to state cancer registries. H.R. 2422, the Action for Dental Health Act, authored by Rep. Robin Kelly (D-Ill.), would improve access to dental care for low-income and underserved individuals. Each of the bills was advanced to the full Committee by voice vote.

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