The 2008 Ryan Haight Online Pharmacy Consumer Protection Act placed strict limits on online prescribing or the use of telemedicine encounters to prescribe controlled substances. The Ryan Haight Act was enacted to address the legal “grey area” in which prescribers and pharmacies operated via the …
One misnomer that has been repeated over the years has been the reference to the “Drug Enforcement Administration” (“DEA”) as the “Drug Enforcement Agency.” This error has appeared not just in articles and other news publications but in some court documents as well. The DEA …
More than a decade ago, FDA began systematically to incorporate review of human factors (HF) design validation within 510(k) reviews. In 2016, the agency issued its definitive HF guidance to guide manufacturers through human factors engineering processes during the development of new medical devices, focusing …
Last October, President Joe Biden directed the Secretary of Health and Human Services (“HHS”) and the Attorney General to begin the administrative process of reviewing current marijuana scheduling under federal law. Then, Congress passed and the President signed the Medical Marijuana and Cannabidiol Research Expansion …
GoodRx is a digital health platform familiar to many, and a prime example of a single player that operates in several different realms of the evolving and growing digital health marketplace. Among its services are prescription drug discounts, telehealth visits, and other health services. The Federal …
Hyman, Phelps & McNamara (“HPM”) Director Larry Houck will present “Prescribing Red Flags, Corresponding Responsibility and DEA Investigations: What’s a Pharmacist To Do?” at this year’s American Pharmacists Association’s (“APhA’s”) Annual Meeting in Phoenix, March 24-27. Mr. Houck was a diversion investigator with the Drug …
On February 15, 2023, the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) held a joint meeting to discuss an application pending before FDA that would switch Narcan (naloxone) Nasal Spray from prescription to over-the-counter (OTC) status. All …
Sections of the radiological health regulations have been updated with the goal of lessening regulatory burdens. The regulations contain many requirements that are over 30 years old. These regulations apply to radiation emitting products, including not just medical devices but all other radiation emitting products …
Chocolate-lovers and hopeless romantics rejoice: FDA has announced that it does not intend to object to the use of certain qualified health claims regarding the relationship between the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease. Though not …
In November of 2020, plaintiffs representing the pharmaceutical industry sued the U.S. Department of Health and Human Services (HHS) to block a rule that would allow the importation of Canadian prescription drugs (see our blog post on the complaint). Last week, the D.C. District Court …
For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market. For founders new to the medical device industry, especially with device types that are often considered novel, the learning curve can be …
In the Spring of 2021, the Health Resources and Services Administration (HRSA) threatened six drug companies with billions of dollars in penalties for not providing 340B discounts to covered entities that sell drugs through vast networks of contract pharmacies (more background on earlier posts). The drug …
Amongst the many provisions that Congress included in the recent Food and Drug Omnibus Reform Act (“FDORA”) were two subtle changes – one change to the Federal Food, Drug, & Cosmetic Act’s (“FD&C Act”) requirements for advancing an investigational new drug into clinical trials and …
FDA has not been shy about its distaste for the Catalyst decision; the Agency has published on its website the litany of problems that arise from it and has sent emails and letters to stakeholders essentially urging them to contact Congress to address the decision. …
