March 1, 2017
2017 is shaping up to be a year in motion—both for our industry and our country. With a new Administration and Congress, continued effects of 2016 statements and warnings from federal agencies, and even personnel transitions within these agencies, 2017 will be full of changes, for better or for worse. As always, AAHP will be your source for regulatory/legislative updates and robust educational programming to help you comply and succeed. The following is on our radar as we move forward into the year.
With the new Administration comes change in both policymakers and policy. AAHP is monitoring these transitions and updates closely. Of particular importance is the newly confirmed Secretary of Health and Human Services, Tom Price, a physician and formerly a republican representative for Georgia. Price is tasked with leading the new Administration’s attempts to roll back the Affordable Care Act and other federal regulations around health care. AAHP believes that the U.S. Food and Drug Administration’s (FDA) drug approval process will remain intact, but other regulation cuts around drug listing and quality metrics may benefit the homeopathic drug industry.
Throughout 2017, AAHP will continue its dialogue with the FDA, especially in light of the agency’s recent inclusion of a homeopathic guidance to its 2017 guidance agenda. We are currently working on written recommendations to submit to the FDA around this issue. AAHP is also creating process validation and final product testing best practices to help our member companies manufacture the highest quality drug products.
Concerning the U.S. Federal Trade Commission (FTC), AAHP plans to both continue discussions as well as support our members in light of the enforcement policy statement issued in November of last year. AAHP is currently developing new disclaimers for advertising and labeling that comply with the policy. Likewise, it is important to note that FTC itself is currently in transition. The White House recently appointment Maureen Ohlhausen (R) as the acting chair, and more changes are coming with the pending nominations of three new commissioners to fill the existing vacancies of the five-member FTC panel. AAHP will keep a close eye on the nomination and confirmation process, and how the “new” FTC’s policies might change.
To continue educating our members, AAHP will once again hold a robust webinar program during 2017. Topics will include pharmacovigilance basics; analytical testing methods; HPUS and starting ingredient updates; and must-know labeling practices (taking in mind the recent FTC enforcement policy).
In addition, AAHP is slated to expand our communications to legislators, members, and the industry as a whole. To this goal, AAHP will continue and intensify our targeted legislator education program, holding in-person meetings on Capitol Hill. We plan to add more content from different industry voices to our monthly newsletter. Moreover, website updates and our first social media program are planned for the coming year.
We look forward to a productive and successful 2017. Over the years, we have worked hard to become the voice and education hub of the industry, and we will continue to do so-to support you, our members.