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FDA Appeals PLAN B Ruling to the Second Circuit; Exclusivity Decision On One-Step Supplement Could Reignite Simultaneous Rx-OTC Marketing Debate
…PLAN B One-Step) available Over-the-Counter (“OTC”) and without point-of-sale or age restrictions (see our previous post here). (Judge Korman recently clarified that the 30-day deadline for compliance with his order…
M.C. Escher By Way of Generic Drug Pricing
…yes, generic competition is anemic for some products, typically more complex products, there is a glut of competition for others. The Drug Competition Action Plan attempts to introduce more competition…
Pennsylvania District Court Decision Signals a New Turn in the Generic Drug Preemption Debate; A Tough Pill to Swallow for the Generic Industry
…points: First, a generic drug manufacturer is not absolved of liability because the FDA has approved its generic product. The Hatch-Waxman Act allows generic drug makers to expeditiously get their…
In Generic PRECEDEX Litigation, Hospira Wins Temporary Restraining Order; Court Orders Recall of Generics, then Backtracks
By Kurt R. Karst – The pace of litigation concerning FDA’s approval of generic versions of Hospira, Inc.’s (“Hospira’s”) PRECEDEX (dexmedetomidine HCl) Injection, 100 mcg (base)/mL packaged in 200 mcg(base)/2…
Schrader Amendment to House UFA Package Creates New “Competitive Generic Therapy” Pathway and 180-Day Exclusivity
…add Section 505H, titled “Competitive Generic Therapies.” As explained by Rep. Schrader in his opening remarks: We know that when generic drugs compete in the market, drug prices come down…
On-Again Off-Again Third Category of Drugs is On Again at FDA; Simultaneous Rx and OTC Marketing Also Up for Debate
…for OTC use in certain women. Historically, a “meaningful difference” exists if the Rx and OTC drug products differ in: (1) active ingredient; (2) indication; (3) strength; (4) route of…
Recent Preemption Decisions Offer a Mixed Bag for Generic Drug Manufacturers
…change without prior FDA approval through the [Changes Being Effected (“CBE”)] process. Yet, 21 C.F.R. § 314.97compels generic manufacturers to “comply with the requirements of §[] 314.70[.]” Section 314.70 includes…
Federal Court Orders FDA to Approve OTC Emergency Contraception Without Restrictions, Describes Intervention by Secretary Sebelius as “Unprecedented” and “Politically Motivated”
…the request. He cited FDA’s previous decision not to commence such proceedings despite “eating up eleven months, 47,000 public comments, and hundreds of thousands, if not millions, of dollars” in…
Office of Generic Drugs “Super Office” Becomes a Reality; New “Office of Generic Drug Policy” Will Handle Hatch-Waxman Issues
…Kathleen “Cook” Uhl, M.D. and OGD Regulatory Counsel Keith Flanagan laid out in presentations the Office’s accomplishments and introduced the GDUFA Steering Committee – a committee composed of senior FDA…
Trump Budget Proposal Would Further Cheapen Generic Drug 180-Day Exclusivity
…Budget states: [T]he Budget proposes to give the Food and Drug Administration (FDA) greater ability to bring generics to market faster by incentivizing more competition among generic manufacturers. This would…
FTC Issues Long-Awaited Final Report on Authorized Generics; Report Examines Both the Short-Term Effects and Long-Term Impact on Competition and Drug Prices
…brand-name companies to compensate generic competitors for delaying entry.” The final report contains four main findings: Competition from authorized generics during the 180-day marketing exclusivity period has led to lower…
No Longer “Waiting for Godot,” Godot has arrived. DEA Finally Issues a Proposed Rule on Suspicious Orders
…New Definitions DEA’s proposed rule establishes three new definitions: (1) “orders received under suspicious circumstances (ORUSC),” (2) “order,” and (3) “due diligence.” DEA’s existing regulations only define a “suspicious order,”…
Further Musings about DEA’s “Suspicious Order” Proposed Rule: What Will a Registrant be Required to Report?
…ordered The order form number for Schedule I and II controlled substances The unique transaction identification number for the suspicious order, and What information and circumstances render the order actually…
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…
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…