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RegBits: 5 Things to Know About Healthcare Product Regulation Today

Posted 11 September 2014 | By Alexander Gaffney, RAC

RegBits: 5 Things to Know About Healthcare Product Regulation Today

Welcome to RegBits, a new way to get an at-a-glance look at important regulatory news stories. Today's top stories include a Republican attempt to circumvent FDA authority, a group calling for FDA to do more on antibiotics, an examination of FDA's "revolving door" in advisory committee meetings, and new efforts to control opioids.

Would OTC Birth Control Drugs Trample FDA Authority?

Birth control pills should be made available over the counter (OTC), but the decision to do so should lie in the hands of FDA, not Congress, write Adam Sonfield and Sneha Barot, both of the Guttmacher Institute, in Health Affairs this week.

The article comes after at least four Republican legislators in the US have called for the pills to be made available more widely in an attempt to remove the issue from battles over mandatory insurance coverage. The 2010 Patient Protection and Affordable Care Act, better known as "Obamacare," requires insurance providers to cover birth control products at no cost (copay) to the consumer. While some women's groups have said the measure would actually increase the out-of-pocket cost for the pills, Sonfield and Barot focus their criticism of the plan on its impact on FDA.

"To switch any drug to OTC status, the typical process involves the drug’s manufacturer submitting an application to the Food and Drug Administration (FDA), which—based on several criteria, including the safety and efficacy profile of the medication—decides whether to grant the request," the authors note. "The FDA process should be driven by the evidence and free from political interference by the administration, Congress, and others."

The authors called the proposals' potential impact on FDA "troubling," and noted that it echoed longtime "political and legal wrangling over minors' access to OTC emergency contraceptive pills."

(Health Affairs)

Group Calls for Antibiotics Limits, Ban

FDA should implement stronger rules on the prescribing of veterinary antibiotics, writes the US Public Interest Research Group (US PIRG) in a new report.

The group cited actions taken by EU regulators between 1972 and 2006, when they banned the practice of feeding antibiotics to animals for "growth promotion." During that time, the group claims antibiotic use did not decline—a fact which makes it unlikely that FDA's recently policy changes on antibiotics will have a similar (lack of) effect.

The group is calling on FDA to restrict the use of antibiotics, even in cases for "disease prevention," and an outright ban on the use of antibiotics "valuable to human medicine" should be instituted as well, the report claims.

(US PIRG Report)

After Report, Call for Fewer Conflicted Advisory Committee Members

The public interest group Public Citizen is calling on FDA to close a loophole which permitted a recurring but temporary member of one of its advisory committees to assume roles as a paid speaker on behalf of a sponsor in front of the same committee.

The group cites the experience of Dr. Milton Packer, who they say served on FDA's Cardiovascular and Renal Drugs Advisory Committee (CRDAC) less than two months before presenting to the same committee as a paid speaker on behalf of Novartis Pharmaceuticals advocating for the approval of one of the company's drugs, serelaxin (Belsomra).

Packer has advocated on behalf of at least five other companies during his 17-year tenure on the committee, the report claims.

The report calls for FDA to close what Public Citizen called a "revolving door."

(Public Citizen)

Opioid Abuse Meeting

FDA will soon hold a long-planned meeting on the development and regulation of abuse-deterrent opioid medications. The public meeting, which will be held on 30-31 October 2014, will reportedly focus on the "scientific and technical issues related to the development and in vitro assessment of these products, as well as FDA's approach towards assessing the benefits and risks of all opioid medications."

The agency has already discussed this meeting with both the brand-name and generic pharmaceutical industries, and is actively soliciting discussion about the "challenges" of developing, manufacturing and assessing abuse-deterrent formulations.

The meeting notice comes almost two years after the release of FDA's draft guidance on abuse-deterrent opioids, and several months after the agency indicated that it wants input on how innovative packaging technologies might prevent the abuse or misuse of opioid medications.

(Meeting Notice)

Undisclosed Side Effects

In a new report released yesterday at the TedMed 2014 conference in San Francisco, the informatics company AdVerseEvents Inc released data obtained from Freedom of Information Act (FOIA) requests showing tens of thousands of previously unreported adverse events.

The data yielded 48,971 new "primary suspect cases yet to be seen outside of FDA and drug manufacturers," the company said in a press statement. The request "revealed significant safety concerns that have yet to be communicated by FDA or drug manufacturers," it added.

(Press Statement)

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