• where experts go to learn about FDA
  • Month: June 2024

    • OTC Hearing Aids: “Nothing to See Here” Says GAO ReportJune 12th, 2024

      It’s been over a year and a half since Over-the-Counter (“OTC”) hearing aids became legal, and it’s not clear that they’ve made the difference in hearing loss treatment that Congress anticipated.  (FDA once estimated that OTC hearing aids would save patients over $3000.)  A recent …

    • HP&M Seeks Attorney with Significant Experience in Government Discount Programs and Price ReportingJune 12th, 2024

      Hyman, Phelps & McNamara, P.C. (HP&M) seeks to add an experienced attorney (7+ years) to our government discount program and price reporting practice. Our ideal candidate will have significant substantive experience working with: Price calculation and reporting under the Medicaid Drug Rebate Program and the 340B …

    • Knock, Knock – FDA Issues Guidance on Best Processes and Practices During BIMO InspectionsJune 11th, 2024

      Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” In an effort to clarify for industry and alleviate some of the stress associated with these activities, last week the FDA issued a draft guidance …

    • HP&M’s Larry Houck A Panelist in FDLI’s Marijuana Rescheduling WebinarJune 10th, 2024

      Last month the Department of Justice and the Drug Enforcement Administration submitted a notice of proposed rulemaking to reschedule cannabis from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III.  Hyman, Phelps & McNamara, P.C. Director Larry Houck will participate as a …

    • More Diversion Cases and WCF’s Opioid & Fentanyl Abuse Management SummitJune 10th, 2024

      It seems as though we cannot get through a week without hearing about controlled substance diversion by employees at another hospital or healthcare facility. We learned this week that Palomar Health, one of California’s largest healthcare districts, agreed to pay $250,000 to resolve allegations that numerous …

    • Will the LDT Rule Make it Easier for Sports Dopers to Go Undetected?June 7th, 2024

      The FDA’s new rule for laboratory developed tests (LDTs), unless overturned through litigation (see here), by legislation, or the election, is going to have profound effects on the U.S. health care system.  At this point, nobody knows all the impacts the rule will have.  But …

    • The OIG Don’t Like That: Rockin’ The Casbah, Rockin’ the CasbahJune 4th, 2024

      Today’s email brings an interesting, and somewhat confusing settlement of what should have been an ordinary antikickback statute case, and may bring about a clash between what many companies do and what the government may be objecting to.  Or, perhaps your loyal blogger is reading …

    • Women’s Health a Focus for FDA and Biden AdministrationJune 2nd, 2024

      FDA’s Office of Women’s Health (OWH) recently celebrated its 30th anniversary.  This office was formed in 1994 to promote the inclusion of women in clinical trials and to provide leadership on topics related to the health of women.  Given that FDA was founded in 1906 and …