Regulatory/Legislation

Congress Aiming to Consider User Fee Legislation in July

July 6, 2017

By Pete Evich, AAHP government relations July 1, 2017 Bills (S 934, HR 2430) that would renew the Food and Drug Administration’s (FDA) ability to collect fees from the drug and medical device industries are expected to get their final votes in the House and Senate in July. The House may consider its bill the…

PDUFA after 25 Years

June 27, 2017

By Mark Land, AAHP president July 1, 2017 The Prescription Drug User Fee Authorization (PDUFA) first enacted in 1992 was the third major piece of drug legislation in the modern era. The first two were the Drug Amendments Act of 1962 and the Drug Price Competition and Patent Term Restoration Act of 1984. PDUFA, like…

The Homeopathic Pharmacopoeia of the United States

May 31, 2017

By Mark Land, AAHP president June 1, 2017 The Homeopathic Pharmacopoeia of the United States (HPUS) is the legal basis for marketing homeopathic drug products in the United States and many other countries around the world. The HPUS is officially recognized in the United States Federal Food Drug and Cosmetic Act and other United States…

Disclaimers in Advertising and Labeling: What Do They Do? Who Does What?

April 26, 2017

By Mark Land, AAHP President The FTC has long recognized that marketing claims may include additional explanatory information to prevent the claims from being misleading. This is FTC’s way of saying disclaimers may cure potentially misleading claims in general or, in our case, homeopathic therapeutic claims specifically. Communicating information to consumers in the noisy marketplace…

United States Food and Drug Administration Office of Pharmaceutical Quality

April 26, 2017

By Mark Land, AAHP President May 1, 2017 The Office of Pharmaceutical Quality (OPQ), created in Jan. 2015, enhances the U.S. Food and Drug Administration Center for Drug Evaluation and Research’s (FDA CDER) Quality Initiative. It creates a drug quality program as robust as the programs the agency already has in place for drug safety…

FDA Office of Surveillance and Epidemiology

April 3, 2017

By Mark Land, AAHP President April 1, 2017 FDA’s Office of Surveillance and Epidemiology (OSE) is positioned within the Center for Drug Evaluation and Research (CDER). OSE evaluates the safety profiles of drugs available to American consumers using a variety of tools and disciplines throughout the life cycle of drugs. OSE maintains a system of…

Consumer Label Comprehension

March 3, 2017

By Mary Borneman, Sr. Director of Communications & Public Affairs, Hyland’s, Inc. March 1, 2017 It’s not news that the Internet and access to information has created what one could argue is the most knowledgeable consumer any business has ever had. From using crowdsourcing and reviews to determine the best electronic or household appliance to…

The FTC and the Web

February 28, 2017

By Alvin J. Lorman, Association Counsel March 1, 2017 The recent claim by the Federal Trade Commission (FTC) that its policy statement on marketing of homeopathic drugs applies to labels and labeling as well as advertising has caused many to ask about the legal boundaries of the FTC’s jurisdiction. When you think of the FTC,…

Congress to Tackle “Must Pass” FDA Legislation Next Year

January 26, 2017

The Prescription Drug User Fee Act (PDUFA) authorizes the Food and DrugAdministration (FDA) to collect fees from Rx pharmaceutical companies to help fund the agency’s drug review work, hire FDA staff, and improve systems. The end goal of this user fee collection system is more timely approval of human drug applications. The regulated industry supports…

What About Your APIs and Q7 Requirements?

January 26, 2017

By Eric L. Foxman, R.Ph. Jan. 26, 2017 In September 2016, the U.S. Food and Drug Administration (FDA) issued a guidance document, entitled Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients—Guidance for Industry. The document applies to the manufacture of Active Pharmaceutical Ingredients (APIs) for use in human drug products and closely follows a…

AAHP monitors and reports on current federal regulations, legislation and government policies that affect the homeopathic community. AAHP is often the first to learn of regulatory changes that have both direct and indirect effects on our industry enabling members to stay ahead of the curve in a rapidly changing healthcare environment.

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