On The Hill

It is widely expected that President Trump will sign H.R. 6, the sweeping opioids package recently passed by Congress, at a White House ceremony next Wednesday. While no administration officials have confirmed the plans, an invitation from the White House says the event will “focus on a year of historic action to combat the opioid crisis.”^[1] Regardless, the president will sign the bill at some point next week, as he has just 10 days from when the Senate sent him the bill to sign or veto.

The new legislation will change the way electronic health records work, and Food and Drug Administration (FDA) Commissioner Scott Gottlieb believes the transition to electronic prescription processes is a key part of combating opioid addiction. In an event with POLITICO Health on Thursday morning, Commissioner Gottlieb said, “The rate of new addiction is a function of prescribing. E-prescribing technology can help rationalize prescribing.”^[2]

Medicaid Work Requirements

In September, Arkansas removed over 4,000 enrollees from the Arkansas Works program due to non-compliance with the work hour reporting requirements. Arkansas was the first state in the nation to implement work requirements for the state Medicaid program. The new regulations, which were approved by the Trump administration this summer, require adults aged 30-49 to report 80 work hours each month to remain eligible. After three months of non-compliance, cases are “closed” and an enrollee is removed from the program. Last month, 4,109 individuals’ cases were closed due to non-compliance, marking the second month Arkansas expelled enrollees from the Medicaid program.^[3]  To read more of the September Arkansas Works Program Report, click here.

FDA Rulemaking

In conjunction with the Department of Health and Human Services (HHS), FDA published a proposed rule this week aimed at increasing access to over-the-counter drugs. The statement of need claimed, “There are certain prescription medications that may have comparable risk-benefit profiles to over-the-counter medications…FDA is proposing regulations that would establish the requirement for a drug product (that) could be marketed as a nonprescription drug product.”^[4] Commissioner Gottlieb has highlighted efforts to make more drugs available over-the-counter, including the opioid overdose reversal drug Naloxone. The proposed rule can be viewed in its entirety here.

FDA is also tackling the issue of flavored cigars, part of an expected push to address e-cigarettes as well. Another proposed rule from HHS seeks to ban all flavored cigars, given the fact that “tobacco products…that are sweet…appeal to youth.”^[5] The flavored cigar rule comment period will end on December 1, 2018. As the agency addresses flavored cigars in the pre-rule stage of the rule-making process, FDA will target flavored e-cigarette products as well. Commissioner Gottlieb said the agency is taking “aggressive steps” to combat e-cigarette use among young people.

^[1] Dan Diamond. “White House to celebrate its opioid work next week.” POLITICO, 18 Oct 2018. https://www.politico.com/newsletters/politico-pulse/2018/10/18/white-house-to-celebrate-its-opioid-work-next-week-377946?tab=most-read

^[2] Scott Gottlieb. “Remarks at POLITICO Health Event.” Twitter, 18 Oct 2018. https://twitter.com/MedResJourno/status/1052904069969469440

^[3] Arkansas Department of Human Services. “Arkansas Works Program September 2018 Report.”  Department of Human Services, 15 Oct 2018. http://d31hzlhk6di2h5.cloudfront.net/20181015/d9/50/39/04/d3b5bd23a6cef7ccec3e4716/101518_AWreport.pdf

^[4] Office of Information and Regulatory Affairs. “Nonprescription Drug Product With an Additional Condition for Nonprescription Use.” Department of Health and Human Services, 17 Oct 2018. https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201810&RIN=0910-AH62

^[5] Office of Information and Regulatory Affairs. “Tobacco Product Standard for Characterizing Flavors in Cigars.” Department of Health and Human Services, 17 Oct 2018. https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201810&RIN=0910-AI28