Selected Milestones Of FDA Regulation Of Nonprescription Drugs

Since Congress in 1962 passed legislation requiring pre-market approval of OTCs, the agency has marked many milestones in its oversight of nonprescription drugs development and manufacturing.

Self-care opportunities have grown in line with FDA’s regulation of OTC drugs. Self-care expert Bill Soller notes milestones in FDA’s oversight of nonprescription drugs since Congress passed legislation in 1962 requiring pre-market approval of OTCs for the first time.
1962	Congress passes Kefauver-Harris Drug Amendments to ensure drug efficacy and greater drug safety. For the first time, OTC drug manufacturers must have FDA’s pre-market approval of their products.
1972	Over-the-Counter Drug Review begins, defining safety, effectiveness and labeling for 96 OTC monograph categories.
1979	Last advisory panel meeting of the OTC Review held by the OTC Miscellaneous Internal Drug Products Advisory Panel.
1979	Professional labeling of aspirin for expanded use of prevention and treatment of stroke and transient ischemic attacks.
1982	FDA issues tamper-resistant packaging regulations to prevent poisonings. The 1983 Federal Anti-Tampering Act makes it a crime to tamper with packaged consumer products.
1984	Congress passes Drug Price Competition and Patent Term Restoration (Hatch-Waxman) Act, establishing exclusivity for brand name drug development.
1984	In arguably the first major post-monograph NDA Rx-to-OTC switch, ibuprofen is approved as a general analgesic/antipyretic; 25 switches occurred from 1976 through 1983, mostly via monograph.
1985	Professional labeling of aspirin expanded for use of prevention of second heart attacks and prevention of first heart attacks in patients with unstable angina.
1992	The Prescription Drug User Fee Act requires drug and biologics manufacturers to pay fees for product applications and supplements, and other services. The act, reauthorized most recently as PDUFA V in 2012, also requires FDA to use these funds to hire more reviewers to assess applications.
1992	FDA OTC Office initiates informal visit to the Nonprescription Drug Manufacturers Association to begin process of assessing new content and format of OTC drug labeling.
1993	FDA consolidates multiple adverse reaction reporting systems as MedWatch for voluntary reporting of problems associated with medical products to be filed by health professionals, foreshadowing AER reporting for OTC medicines.
1994	First meeting of FDA’s Nonprescription Drugs Advisory Committee.
1994	FDA announces it could consider regulating nicotine in cigarettes as a drug, in response to a citizen petition by the Coalition on Smoking Or Health, presaging OTC nicotine-containing products.
1995	FDA approves Rx-to-OTC switches of H-2 blockers cimetidine, famotidine and ranitidine as acid reducers. SmithKline, since merged with Glaxo Wellcome to become GlaxoSmithKline, marketed Tagamet HB as a cimetidine product; McNeil Consumer Healthcare launched famotidine into the OTC space as Pepcid AC; and ranitidine initially was available OTC as Zantac 75 by Glaxo Wellcome.
1996	An NDA for OTC nicotine polacrilex approved for smoking cessation. GlaxoSmithKline launched the product under the Nicorette brand.
1996	Butoconazole approved as an OTC anticandidal treatment. Bayer marketed the product as Femstat 3.
1997	Triclosan approved for prevention of gingivitis. Colgate-Palmolive used the ingredient in Total Toothpaste.
1997	Chromolyn sodium approved for prevention of allergy attacks. The brand of the initial OTC product with the ingredient, NasalCrom, no longer is available.
1998	Aspirin, acetaminophen, caffeine approved as OTC migraine treatment. Novartis marketed the drug as Excedrin Migraine.
1999	Final rule published mandating OTC Drug Facts Label in a standardized "consumer friendly" format and content.
2000	The Supreme Court upheld a lower court’s decision in FDA vs. Brown & Williamson Tobacco Corp. et al., ruling 5-4 that FDA does not have authority to regulate tobacco as a drug.
2006	FDA approves levonorgestrel (.75 mg /2) switch as OTC emergency contraceptive with age restriction and pharmacy-only sales. Barr Pharmaceuticals, since acquired by Teva Pharmaceutical Industries Ltd., marketed the drug as Plan B.
2006	Congress passes the Dietary Supplement and Nonprescription Drug Consumer Protection Act requiring OTC drug and dietary supplement firms to submit reports on serious adverse events to FDA.
2007	FDA approves OTC switch of orlistat for weight loss. GlaxoSmithKline marketed the drug as alli.
2012	FDA initiates program to explore "Using Innovative Technologies and other Conditions of Safe Use to Expand Which Drug Products Can Be Considered Nonprescription," and later names the program, Nonprescription Safe Use Regulatory Expansion initiative.
2013	Following protracted litigation with women’s health care advocates, FDA agrees to allow sales of Plan B One-Step (levonorgestrel 1.5 mg) without age or point-of-sale restrictions, while generic one- and two-dose levonorgestrel products remain behind the counter and subject to consumer age verification.
2013	FDA approves OTC switch of transdermal oyxbutynin for women’s overactive bladder. Merck & Co. launched the product with the Oxytrol For Women brand.
2013	FDA approves OTC switch of intranasal steroid tiamcinolone for allergy and congestion. Sanofi plans to launch the product in 2014 as Nasacort Allergy 24HR.