Health Policy Report (2/24)

The Week in Review

Sen. Bernie Sanders (I-VT) has taken the lead for the Democratic presidential nomination after a dominant victory in Saturday’s Nevada caucuses. The Vermont Senator earned 39 percent of the vote in the Silver State’s contest, besting former Vice President Joe Biden and former South Bend, IN Mayor Pete Buttigieg who finished second and third respectively. The race for the Democratic nomination now shifts to South Carolina’s Feb. 29 primary, where recent polling suggests a tight race between Sen. Sanders and Vice President Biden.

The Week Ahead

Congress will return from the Presidents’ Day district work period to resume legislative business, with the Senate returning later this afternoon and the House picking back up tomorrow. On the Senate floor next week, Majority Leader Mitch McConnell (R-KY) has queued up a pair of abortion-related measures that are designed as a messaging exercise for the 2020 election. The measures up for consideration would: (1) establish requirements for the degree of care a health care practitioner must exercise in the event a child is born alive following an abortion or attempted abortion (S. 311); and (2) seek to boost protections for pain-capable unborn children (S. 3275). Senators will also consider four presidential nominations, including Katharine MacGregor’s nomination to be Deputy Secretary of the Interior.  

Meanwhile, House lawmakers have queued up a comprehensive tobacco-related measure that seeks to curb the use of e-cigarettes among youths. Specifically, the Reversing the Youth Tobacco Epidemic Act would amend the Federal Food, Drug, and Cosmetic Act to: (1) prohibit the sale of flavored tobacco products; (2) promulgate Food and Drug Administration (FDA) regulations on synthetic nicotine and graphic health warnings for cigarette packing; and (3) ban the marketing, advertising, or promotion of any e-cigarette products to individuals under the age of 21. The lower chamber will also consider suspension bills out of the House Natural Resources and Veterans’ Affairs Committees.

Support for Sen. Grassley’s Drug Pricing Bill Grows

Sen. Joni Ernst (R-IA) announced her support for Sen. Chuck Grassley’s drug pricing package (S. 2543) last week. The Senate Finance Committee Chair had previously indicated that he estimates he will need the support of at least 25 Senate Republicans before Majority Leader Mitch McConnell (R-KY) is comfortable bringing the bill to the Senate floor for a vote, and has been meeting with Senators one-on-one to quell concerns and garner support. Sen. Grassley has also reportedly altered the bill text in order to gain more Republican support, although has remained mum on which aspects were changed. Sen. Ernst joined a group of roughly 12 fellow Republicans willing to support the bill, including Sen. Martha McSally (R-AZ), Sen. Susan Collins (R-ME), Sen. Cory Gardner (R-CO), and Sen. Thom Tillis (R-NC). Despite growing support, the bill still faces tough prospects given that many Republican senators object to one of its key provisions, which would limit drug price increases in Medicare to the rate of inflation, denouncing it as a “price control.”

Coronavirus Epidemic Sparks Fears of Drug Shortages, Sanofi to Work on Vaccine

The growing worldwide coronavirus epidemic has prompted drug supply shortage fears from lawmakers worried about China’s impact on the drug supply chain. Lawmakers have been increasingly focused on U.S. reliance on China for pharmaceutical manufacturing, and many have introduced legislation to address shortages and relocate manufacturing to the United States. As of earlier this month, no manufacturers have notified the Food and Drug Administration of any potential risks to the supply chain, although health experts are expecting the epidemic to eventually have impact on manufacturing capabilities. House Energy & Commerce Committee Chairwoman Anna Eshoo (D-CA) noted recently that the U.S. cannot be dependent on a foreign source for pharmaceutical manufacturing that is not “exactly a 100 percent ally,” and has been looking at the issue since the Committee held a hearing on the drug supply chain last fall. An odd coalition of senators — including Sen. Elizabeth Warren (D-MA) and Sen. Tom Cotton (R-AR) — wrote to the Pentagon in December, concerned about how a pharmaceutical supply chain disruption could affect military readiness. Additionally, Senate Minority Leader Charles Schumer (D-NY) asked the Government Accountability Office in December to examine U.S. reliance on China for pharmaceuticals.

Last Monday, drug manufacturer Sanofi announced it will partner with the U.S. Biomedical Advanced Research and Development Authority to develop a vaccine against coronavirus. Sanofi officials noted their previous work to develop a vaccine for SARS will assist them in the development, as well as the company’s recombinant DNA platform. The manufacturer warned that the timeline could still be extended even with emergency use approval and will likely take three or four years. Sanofi expects to have a vaccine candidate to test in the lab within six months and could be ready to test a vaccine in people within a year to 18 months. Johnson & Johnson’s vaccine division, Janssen, has also announced it will try to produce a vaccine. Nearly four dozen lawmakers asked the Department of health and Human Services last Thursday to ensure any treatment for coronavirus developed with taxpayer funds is reasonably priced and note given an “exclusive license.”

FDA Finalizes New Biological Product Definition

On Thursday, the Food and Drug Administration (FDA) finalized a new definition for biological products. By expanding the definition to include “chemically synthesized polypeptides,” which include many insulin products, FDA is opening insulins up to biosimilar — rather than generic — competition. Given the complex structure of insulin, this should have the effect of facilitating the entry of follow-on products into the market. Some other drugs will be affected by this change, including certain fertility drugs and growth hormones. While the biosimilars pathway will now be open for creating follow-on products for chemically synthesized polypeptides, innovator products will now be allotted twelve years of marketing exclusivity, as opposed to five years for small-molecule drugs.

Congress initially excluded chemically synthesized polypeptides from the definition of a biological product in the Biologics Price Competition and Innovation Act. In December, Congress reversed course and struck that exclusion from the definition of biological product in its year-end spending bill. In updating the definition, FDA is simply following Congress’s lead and ensuring that regulation conforms with the recently changed statute.

Health Care Policy a Flash Point in Democratic Debate

Health policy once again spurred heated discussion during last Tuesday night’s debate between the remaining Democratic presidential hopefuls. The stage was set when Nevada’s Culinary Workers Union came out against Senator Bernie Sanders’ (I-VT) “Medicare for All” plan out of concern that it would eliminate the generous coverage secured by the union and replace it with an uncertain benefits package. During the debate, Senator Sanders’ rivals, including Senator Amy Klobuchar (D-MN), piled on, saying that the Culinary Workers had negotiated a package that was right for them.

Senator Elizabeth Warren (D-MA) came out swinging on health care, calling former South Bend, Indiana Mayor Pete Buttigieg’s plan “not a plan” but “a PowerPoint,” saying Senator Klobuchar’s plan amounts to two bullet points, and calling Senator Sanders’ plan “a good start” while criticizing him for inflexibility around it. Meanwhile, former Vice President Joe Biden continued to vigorously defend and promise to strengthen the Affordable Care Act. Senator Sanders attacked Mayor Buttigieg for accepting campaign donations from private interest in the health care sector, including employees and executives at insurance and pharmaceutical companies. Meanwhile, former New York City Mayor Mike Bloomberg implied that 160 million Americans “love” their current health insurance. Polling shows that people who have coverage are mostly satisfied with it.