In this post, we’ll delve into Biden's drug czar pick, the current landscape concerning COVID-19 booster shoots, and the Biden administrations' stance on march-in rights.
On Tuesday, President Biden nominated Rahul Gupta, a former West Virginia health official, to lead the Office of National Drug Control Policy (ONDCP) and steer the response to the opioid epidemic. Gupta is a primary-care doctor who previously served as West Virginia’s health commissioner, led Biden’s transition efforts for the drug policy office and serves as the top health official at maternal and child advocacy group March of Dimes. Gupta would be the first physician to serve as drug czar if confirmed by the Senate. The ONDCP was created in 1982 with the support of Biden, who coined the term “drug czar.” The ONDCP coordinates national policy around fighting substance-use disorders, including the response to an opioid crisis that has worsened during the pandemic. Overdose deaths rose nearly 30 percent from November 2019 to November 2020. Gupta has publicly warned that the pandemic probably exacerbated addiction-related public health problems, citing the shift from in-person care. In his tenure we can expect to see efforts to increase access to treatment for patients with addiction. Gupta would replace Regina LaBelle, who has served as the office’s acting director since January.
Last week, Pfizer and BioNTech announced that they had observed waning immunity in people who had been vaccinated and that they planned to seek emergency-use authorization for a booster dose in August. In a private meeting with top US scientists and regulators on July 12, Pfizer’s representatives argued that the US should move to authorize a third shot to maintain the highest levels of protection. However, the Centers for Disease Control and Prevention and the Food and Drug Administration issued a rare joint statement emphasizing that fully vaccinated Americans do not need a booster shot at this time, and the Department of Health and Human Services echoed their sentiment. Pfizer and BioNTech said real-world data from the Ministry of Health in Israel showed that protection against symptomatic infection declined in the six months after vaccination, findings which were consistent with data from their own phase 3 study. They noted that a third dose would be needed within six to 12 months after full vaccination; the booster would enhance the levels of neutralizing antibodies by a factor of five to 10. The companies are also working on a booster aimed at the delta variant. Four countries have announced booster programs, including Israel, which has been battling a delta outbreak. Israel began administering third shots on Monday to people with weakened immune systems, including cancer patients and organ transplant recipients.
The Biden administration paused a rule that would prevent the federal government from using march-in rights to combat the high prices of products developed with government funding. The rule was proposed earlier this year by the Trump administration, and the decision to pause suggests the Biden administration is responding to pressure to widen access to medicines and vaccines, especially those funded in part by the U.S. treasury, in the face of the Covid-19 pandemic. March-in rights were created through the Bayle Dohl Act, and they allow a government agency that funds private research to license its patent to another party in order to alleviate health and safety needs which are not being reasonably satisfied. An agency can also do so when the benefits of a product, such as a medicine, are not available on reasonable terms. Over the last several years, a growing number of consumer advocates, academics, and lawmakers have argued that medicines invented with taxpayer dollars should be affordable to Americans. But exercising march-in rights would chill the willingness among drug makers to work with federal agencies and, subsequently, harm innovation.
In its executive order issued last Friday, the Biden administration instructed the Department of Commerce to consider not finalizing any provisions on march-in rights and product pricing in the proposed rule. The executive order, which was touted as a bid to promote business competition, also contained various proposals to address the cost of prescription medicines. March-in rights have never been exercised, the National Institutes of Health is responsible for sanctioning said action and they have rejected various requests to pursue march-in rights for various medicines. To what extent, if any, the move by the Biden administration will result in the use of march-in rights to lower the cost of medicines is unclear, but it would be outside the scope of acceptable reasoning, to simply exercise march-in rights for price-setting. However, the decision to pause the rule appears to reflect a shift in Biden administration thinking toward patents more broadly, which recently embraced a proposal at the World Trade Organization to temporarily waive intellectual property protections for Covid-19 vaccines.