The temperatures outside are dropping, but Jack Frost is not responsible for the cooling relationship between FDA and the dietary supplement industry. Trade groups respond icily to new dietary ingredient notification draft guidance that they say contravenes the Dietary Supplement Health and Education Act. Most groups agree FDA should rewrite the guidance, but “The Tan Sheet” combs through individual comments to highlight the finer points.
HHS Secretary Sebelius also sent a chill through the drug industry when she blocked Teva Pharmaceutical Industry’s attempted full OTC switch of emergency contraceptive Plan B. We look at why Sebelius overrode FDA’s recommendation to make the pill available OTC to all females of childbearing age, and analyze the potential impact the interference could have on future switch attempts and the potential creation of a third drug class.
We also look at FDA’s enforcement priorities for the New Year and its progress on foreign food facility inspections.
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"The Tan Sheet," Dec. 12, 2011, Vol. 19, No. 50
Dietary Supplements
UNPA Cleans Up Industry Ingredient Lists To Push For FDA Acceptance -- The United Natural Products Alliance culls 273 ingredients from the supplement industry’s qualified lists, which the trade group asks FDA to accept as proof of an ingredient being marketed before Congress passed DSHEA.
AHPA Rewrites NDI Guidance, Argues FDA Proposes Premarket Approval For Supplements -- The NDI draft guidance “seeks to erect extra-legal barriers to market entry” and change supplement regulation “from the notification process described under law to an FDA approval process,” AHPA argues, joining other trade groups urging FDA to withdraw the guidance.
NDI Draft Guidance Comments In Brief -- USP urges compendium compliance in lieu of NDI Firms whose ingredients comply with compendial standards should be exempt from filing new dietary ingredient notifications, the U.S. Pharmacopeia says in Dec. 2 comments to FDA on the NDI notification draft guidance.
Rx-to-OTC Switch
FDA’s Jenkins Revives Intermediate Drug Class Talk In Plan B’s Wake -- FDA new drugs chief John Jenkins says the Plan B decision and failed statin switch attempts should prompt a discussion of alternative pathways to drug access. The current prescription/nonprescription system “maybe … doesn’t work very well’ for some drugs, he says.
Teva Plan B OTC Application Fails Political Test After Clearing FDA Hurdle -- HHS Secretary Sebelius says Teva must show more evidence of how young adolescent females would use Plan B One-Step as an OTC. But obtaining such clinical data for the emergency contraceptive – in excess of what FDA already needed to approve it – appears nearly impossible, experts say.
HHS’ Plan B Interference Could Rattle Industry -- Drug industry stakeholders voiced concern about the potentially far-reaching impacts of Health and Human Services Secretary Kathleen Sebelius quashing OTC access for Plan B One-Step. For regulated industry, the HHS override of a scientific review suggests a new paradigm for the department’s oversight of FDA, said food and drug attorney Stephen Mahinka.
FDA
FDA Enforcement Priorities Include Globalization Threats -- FDA will overhaul its enforcement approach to reflect the impact of globalization by partnering more with foreign counterparts, streamlining inspections, recalls and emergency responses and using stiff criminal sanctions to deter noncompliance, agency officials say.
Former Food Safety Chief Doubts FDA Can Meet Foreign Inspection Mandate --The food safety law requires FDA to do more than 19,000 foreign food facility inspections in fiscal 2016, but former agency official David Acheson says, “It is not going to happen.” Acheson and other experts also question the logistics of the third-party auditor accreditation program the law established.
Regulatory
United Front For NDI Guidance Withdrawal Faces Steep Odds -- FDA likely will not follow supplement industry trade groups’ suggestion that the agency withdraw the draft guidance on new dietary ingredient notifications.
Agencies Target “Fraud-Driven” HCG Weight-Loss Ingredient -- FDA and FTC warn seven firms that “homeopathic” HCG weight-loss products are unapproved new drugs with unsubstantiated claims. An FTC official says HCG is the latest “fraud driven” weight-loss ingredient.
News in Brief
In Brief -- Canada shifts energy drinks, possibly other NHPs to foods; Consumer Reports takes on fish oil; OTC diabetic products lift Hi-Tech sales; MJN restructures management and LipiGesic M sold at CVS, Walgreens.
-- Elizabeth Crawford (e.crawford@elsevier.com)
