On January 17, 2018, in an effort to overhaul the regulation of over-the-counter (OTC) monograph drugs, U.S. Senators Johnny Isakson and Bob Casey introduced bipartisan legislation, the Over-the-Counter Drug Safety, Innovation, and Reform Act, S.2315. As readers of this blog know, the current monograph system, which …
As previously discussed, pursuant to a consent decree, FDA was to finalize the over-the-counter (OTC) topical health care antiseptic drug products monograph with respect to triclosan by January 15, 2018. Rather than limiting the rulemaking to the single active ingredient, triclosan, FDA took it upon …
As readers of this blog may recall (see here), the purpose of the Sunscreen Innovation Act (SIA) was to speed up FDA’s review of time and extent applications (TEAs). TEA process provides a pathway for adding an active ingredient to an existing over-the-counter (OTC) drug …
Public Citizen sued FDA last week, in an effort to force Agency action on the tentative final monograph (“TFM”) for OTC oral health care drug products. That TFM currently permits the marketing of OTC benzocaine oral health care drug products labeled for use to relieve …
Cue up “For The Love of Money” by The O’Jays (and theme song of The Apprentice) . . . The Trump Administration’s Fiscal Year 2018 Budget Proposal is out! On May 23, 2017, The White House Office of Management and Budget released President Trump’s Fiscal Year …
As previously reported, on May 1, 2015, FDA issued a proposal to amend the 1994 Tentative Final Monograph (TFM) for the over-the counter (OTC) health care antiseptic drug products, including health care personnel hand washes, health care personnel hand rubs, surgical hand scrubs, surgical hand …
By Riëtte van Laack – As we blogged previously, there have been activities both by FDA and the FTC foreboding a bleak future for homeopathic products. Both FDA and the FTC questioned the policies and standards applicable to homeopathic products. The FTC threatened to hold homeopathic products …
By Riëtte van Laack – The Sunscreen Innovation Act (SIA) was enacted in 2014. It amended the FDC Act to provide specific deadlines for FDA’s review of time and extent applications (TEAs ) for sunscreen active ingredients. Thus far, FDA has proposed sunscreen orders for all …
By Riëtte van Laack – Last week, FDA announced its final rule regarding over-the-counter (OTC) consumer antiseptic wash products. As we reported in 2013, FDA issued a proposal to declare all antimicrobial consumer hand wash products as not generally recognized as safe and effective but invited comments …
By Riette Van Laack – On June 30, as required under the consent decree in the action by the National Resource Defense Council against FDA (see our previous post here), FDA published the amended tentative final monograph for consumer antiseptic rubs, also referred to as consumer rubs, leave …
By Kurt R. Karst – There are general life certitudes, such as the quote attributed to Benjamin Franklin: “In this world nothing can be said to be certain, except death and taxes.” There are also FDA certitudes we’ve come to recognize. For example, “everything eventually goes generic” …
By Riëtte van Laack – As required by the Sunscreen Innovation Act (SIA), FDA published its proposal for the review of Time and Extent Applications (TEAs) for non-sunscreen ingredients (the SIA lays out the framework for sunscreen ingredients). It now is evident that a TEA will …
By Riëtte van Laack – In 2002, FDA issued regulations providing for a process, the Time and Extent Application (TEA), to create a new Over-the-Counter (OTC) drug monograph or amend an existing monograph to recognize that an active ingredient or condition (e.g., dosage form) is Generally …
By Riëtte van Laack - As we previously reported, FDA and FTC are reviewing their regulation of homeopathic drugs. In March 2015, FDA issued a notice requesting comments on the current use of homeopathic drugs, and that agency’s approach to regulation of the category. In June 2015, FTC …
By Kurt R. Karst – Earlier this month, legislation was introduced in both the U.S. Senate and U.S. House of Representatives to fund FDA for the next fiscal year: Fiscal Year 2016. Both the Senate bill and the House bill, titled “Agriculture, Rural Development, Food and …
