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Surprise! FDA Quickly Issues Compounding Draft Guidances
…oversight and regulation of the practice of pharmacy.” The guidance states, however, that FDA intends to continue to cooperate with State authorities to “address pharmacy activities that may be violative”…
Stimulating Privacy: Changes to HIPAA in the Stimulus Bill
…a third party was funding the communication. Thus, a manufacturer could without a patient authorization pay a doctor or pharmacy to send prescription refill reminders to patients as well as…
FDA Issues Final Guidance Addressing Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities
…or 30 days after the shortage ends (which is a new guidance provision)). The drug must be repackaged by a state-licensed pharmacy, federal facility or outsourcing facility, and under the…
Patient Groups Sue HHS, CMS for 2020 Rule Allowing the Use of Copay Accumulator Programs
…individual to present at the pharmacy. The pharmacy bills all or most of the individual’s copayment or coinsurance—which the patient would otherwise pay the pharmacy directly—to the manufacturer. Insurance companies…
CMS and OIG Propose Changes to the Stark Law, Anti-Kickback Statute and Civil Monetary Penalty Rule
…whether to exclude pharmaceutical manufacturers, manufacturers and distributors of durable medical equipment (DME), pharmacy benefit managers, wholesalers, and distributors from the definition of “VBE participant,” or, alternatively, to impose a…
The Wait is — Almost — Over: The Long-Anticipated Proposed Rule for Drug Wholesale Distributors and 3PLs is Out: Comments Due in 120 Days
…2013 report prepared by the National Association of Board of Pharmacy (“NABP”) titled Wholesale Drug Distribution: Protecting the Integrity of the Nation’s Prescription Drug Supply as well as NABP’s Model…
Minnesota Proposes to Reduce Opioid Product Registration Fees Related to Hospitals
…exemption for injectable opiates distributed to a hospital or hospital pharmacy, then the Board of Pharmacy would refund the fee to the manufacturer. The companion bill was already passed by…
FDA Calls for Comments Addressing Compounding Animal Drugs; Interested Persons Should Weigh In on Specific Topics Identified by the Agency
…pharmacy, state boards of veterinary medicine)? If so, how many reports on average does each state-licensed pharmacy and veterinarian submit to these state agencies each year? For purposes of the…
Would You Balk at Disclosing Confidential Information to Your Competitors?
…license for use of an aspect of the [ETASU] for the applicable listed drug and that it was unable to obtain a license. ETASU REMS have been a difficult pill…
A Short-Term Gain for a Long-Term Loss? The Build Back Better Act’s Medicare Drug Price Negotiation Program Ignores Hatch-Waxman/BPCIA Realities . . . and that May Mean Big Bad Business for Generic Drug/Biosimilar Manufacturers
…product enough to obtain market share sufficient to offset their [development] costs.” That’s a difficult pill to swallow. It means less – or no – generic/biosimilar competition. After all, given…
Please Pass the Brownies – Uh – “Edible Retail Marijuana Products”
…Product” to mean “any Retail Marijuana Product which is intended to be consumed orally, including but not limited to, any type of food, drink, or pill” (emphasis added). The rules…
Long Time Passing: Where Have All the De Novo Decision Summaries Gone?
…DEN220044 02/03/2023 560 OHT7: Office of In Vitro Diagnostics PMD-200 DEN210022 02/17/2023 546 OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Pill Sense System DEN220065 02/24/2023 539 OHT3:…
Preemption Cases Involving FDA-Regulated Products are Increasing – Third Circuit Rules that FDA Approval Preempts State False Labeling Claims & Supreme Court Petitioned to Review REZULIN Case
…benefits to eligible Commonwealth of Pennsylvania employees, retirees, and their dependents, sued AstraZeneca alleging, among other things, that the company unlawfully advertised NEXIUM (esomeprazole magnesium) (i.e., the “Purple Pill”) in…
FDA Will Approve Plan B Without a Prescription for 17-Year Olds
…morning after pill, is an emergency contraceptive that can be used to reduce the risk of unwanted pregnancy if taken within 72 hours of unprotected sex or the failure of…
Federal Court Orders FDA to Approve OTC Emergency Contraception Without Restrictions, Describes Intervention by Secretary Sebelius as “Unprecedented” and “Politically Motivated”
…scathing opinion that reproached Secretary Sebelius for acting in bad faith and for allowing political considerations to trump the expertise of FDA’s scientists, Judge Korman stressed the importance of evidence-…