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On-Again Off-Again Third Category of Drugs is On Again at FDA; Simultaneous Rx and OTC Marketing Also Up for Debate
…medicine containing pseudoephedrine, which, under the Combat Methamphetamine Epidemic Act of 2005, is limited to Behind-the-Counter (“BTC”) sales. Previous explorations to create a third category of drugs have petered out. …
Senate and House Lawmakers Add to FDA’s To-Do List in Fiscal Year 2016 Appropriations Bills
…consist of: $18,500,000 for Inspection Modernization and Training; $5,000,000 for the National Integrated Food Safety System; $11,500,000 for Education and Technical Assistance for Industry; $2,500,000 for Technical Staffing and Guidance…
FDA Appeals PLAN B Ruling to the Second Circuit; Exclusivity Decision On One-Step Supplement Could Reignite Simultaneous Rx-OTC Marketing Debate
…of simultaneous prescription and OTC marketing of the same drug. As we previously discussed, FDA has relied on FDC Act § 503(b), generally, to assert that, absent a “meaningful difference,”…
A Round Up of New State Laws to Control Drug Prices
…prescription drug price data from payors, providers, prescription drug manufacturers, wholesale drug distributors, and pharmacy benefit managers (PBMs). Previously, only payors and providers needed to report clinical, financial, and quality…
No Longer “Waiting for Godot,” Godot has arrived. DEA Finally Issues a Proposed Rule on Suspicious Orders
…to distribute controlled substances: distributors, manufacturers, importers, pharmacies, hospital/clinics teaching institutions, practitioners, Mid-level Practitioners (MLP), MLP- Ambulance Services, Researchers, Analytical Labs and NTPs,” but not reverse distributors. The Two-Option Framework…
Federal Court Orders FDA to Approve OTC Emergency Contraception Without Restrictions, Describes Intervention by Secretary Sebelius as “Unprecedented” and “Politically Motivated”
…label and use the drug appropriately, then it would be impossible for any drug to be approved for over-the-counter sales without a prescription.” Moreover, Judge Korman described Ms. Sebelius’ “unprecedented…
What the Doctor Ordered? What the Pharmacist Understood? FDA Issues Compounding Draft Guidance Addressing Compounding for Office Use under FDC Act § 503A
…drug is compounded in limited quantities consistent with FDA’s guidance on anticipatory compounding, FDA makes clear that the “drug product must be compounded after receipt of a valid prescription, which…
Amarin Announces a Proposed Settlement of its First Amendment Lawsuit Against FDA: Coming Full Circle in a New Era of the Regulation of Off-label Promotion
…for the proposed supplemental use could constitute ‘misbrand[ing] under the Federal Food, Drug, and Cosmetic Act [(“FD&C Act”)].’” Complaint at 27, Amarin Pharma, Inc. v. FDA, No. 15-3588 (S.D.N.Y. May…
GAO Recommends Coordination and Assessment of Federal Efforts to Educate About Prescription Pain Reliever Abuse and Misuse
…to 2009. “Abuse” and “misuse” refer to using a prescription pain reliever to get high, using a prescription pain reliever for pain relief without a prescription or using a prescription…
DEA Proposes Rule to Expand Partial Filling of Schedule II Prescriptions; Will the Benefit be Cost-Effective?
…of the prescription at the time that it is completed (or, in the case of an emergency oral prescription, directly stating to the pharmacist when such prescription is communicated to…
New York District Court Rebukes FDA Over PLAN B OTC Switch Approval Decision; Vacates FDA Citizen Petition Decision and Remands to FDA
…switch.” For example, FDA upper management, including the Commissioner, wrested control over the decision-making on Plan B from staff that normally would issue the final decision on an over-the-counter switch…
Drug Compounding: FDA Issues Final Guidance on Section 503A’s Individually Identified Prescription Requirement – With At Least Three Noteworthy Changes
…guidance, FDA proposed that, to be a valid prescription order for a compounded drug product, the prescription order needed to state clearly that it is for a compounded drug and…
Congress Passes Legislation To Regulate Controlled Substance Dispensing Over the Internet
…“knowingly or intentionally delivers, distributes, or dispenses, or offers or attempts to deliver, distribute, or dispense, a controlled substance by means of the Internet” but does not include registered manufacturers…
What to Do When You Receive a DEA Order to Show Cause
You may be a doctor, dentist, veterinarian, pharmacy, wholesale distributor, or manufacturer, and you just received an Order to Show Cause from the Drug Enforcement Administration (DEA). An Order to…
Biden “Promoting Competition” Executive Order Falls In Behind Drug Importation
…Food, Drug, and Cosmetic Act in 2003 to authorize the importation of prescription drugs from Canada under certain conditions, but until 2020, no administration had made the statutorily required certification…