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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
…. . . The FDC Act was amended in 1951 by the Durham-Humphrey Amendment, Pub. L. No. 82-215, 65 Stat. 648 (1951), to give FDA the authority to require that…
FDA Appeals PLAN B Ruling to the Second Circuit; Exclusivity Decision On One-Step Supplement Could Reignite Simultaneous Rx-OTC Marketing Debate
By Kurt R. Karst – By now everyone knows that FDA has appealed to the Second Circuit (Case No. 13-1690) the April 5, 2013 Memorandum and Order and April 10, 2013…
Has FDA Already Resolved One Critical Issue Concerning Forced Rx-to-OTC Switches?
By Kurt R. Karst – FDA’s ability to force a prescription-to-over-the-counter switch (“Rx-to-OTC switch”) has been hotly contested over the past decade. The crux of the debate concerning forced Rx-to-OTC…
An FDA Warning Letter that Does Not Add Up: OTC Drug Monograph Combination Products With Conflicting Dosing Directions
…of effectiveness. [(60 Fed. Reg. at 10,286, 10,290 (Feb. 23,1995))] . . . and The antitussive directions are 5 to 10 mg every hour as needed, while the anesthetic/analgesic directions…
Federal Court Orders FDA to Approve OTC Emergency Contraception Without Restrictions, Describes Intervention by Secretary Sebelius as “Unprecedented” and “Politically Motivated”
…available Over-the-Counter (“OTC”) and without age restrictions. In doing so, Judge Edward R. Korman of the U.S. District Court for the Eastern District of New York strongly criticized Kathleen Sebelius,…
GAO Report on Over-the-Counter Drugs
…order for sunscreen. GAO also included a brief description of the 15,000 comments FDA received on the proposed sunscreen rule. FDA informed GAO that 1,100 of the comments were unique…
Obama Administration Gives Up Fight Over PLAN B After Second Circuit Issues Split Decision on Motion for Stay Pending Appeal
…the Eastern District of New York indicating that FDA and HHS have complied with his April 10, 2013 Judgment by granting a 2001 Citizen Petition (Docket No. FDA-2001-P-0123) and will…
New York District Court Rebukes FDA Over PLAN B OTC Switch Approval Decision; Vacates FDA Citizen Petition Decision and Remands to FDA
…to switch PLAN B (and all emergency contraceptives like it) from prescription-only to OTC status without age or point-of-sale restrictions. FDA’s August 24, 2006 approval permitted Over-the-Counter (“OTC”) use of…
Sanofi Sues FDA to Prevent Disclosure of OTC NASACORT Labeling Before Product Launch; Claims FOIA Exemption 4
…to be a first-of-its-kind lawsuit. Sanofi alleges that FDA’s decision to make public a copy of the labeling approved on October 11, 2013 under NDA No. 020468 for the Over-the-Counter…
McNeil Petitions the U.S. Supreme Court on OTC Drug Labeling Failure-to-Warn Preemption Issue
…requirement under [the FDC Act], the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.).” In…
Reps. Waxman and Allen and Sen. Kennedy Will Introduce Bill to Modernize the OTC Drug System
…by amending OTC drug monographs . In October 2007, FDA’s Nonprescription Drugs and Pediatric Advisory Committees recommended, during a joint committee meeting, a ban on the use of OTC cough/cold…
New CDRH EUA Doorbuster! Validate a Point-of-Care or Rx Home-Use Device and You Have a Chance to Walk Away with a Brand New OTC Claim!
…CLIA Lab Point-of-Care Rx-Only Home-Use (Symptoms Confirmed) Rx-Only Home-Use (Suspected Exposure) OTC Home-Use (Asymptomatic or No Suspected Exposure) PPA >80% >80% 80-90% >90% ≥90% NPA >80% >80% ≥99% ≥99% ≥99%…
Senate and House Lawmakers Add to FDA’s To-Do List in Fiscal Year 2016 Appropriations Bills
…over Fiscal Year 2015 funding. In addition to funding FDA, however, the bills (S. 1800 and H.R. 3049) and their accompanying reports (H. Rept. 114-205 and S. Rept. 114-82) heap…
U.S. Cattlemen Petition USDA to Address “Made in USA” and “Product of USA” Claims
…and require that any beef product labeled as “Made in the USA,” “Product of the USA,” “USA beef,” or otherwise indicated to be U.S. beef, come from cattle that have…
FDA Publishes Two Draft Guidance Documents on the Reporting of Serious Adverse Events Associated with OTC Drugs and Dietary Supplements
…distributor whose name . . . appears on the label of an OTC drug marketed in the United States without an approved application . . . must submit to FDA…