The AAFP recently responded to the FDA's request for suggestions of regulations that could be modified or repealed by telling the agency to not hit the brakes on issues that affect public health.
The Academy outlined its positions on public health priorities for which the FDA has authority in a Dec. 6 letter(3 page PDF) signed by Board Chair John Meigs, M.D., of Centreville, Ala. Several of the issues, including menu labeling and regulation of electronic cigarettes, were the subjects of other letters to the agency this year.
One priority is ensuring that the FDA extends its regulatory jurisdiction to tobacco products, including cigars and electronic cigarettes. The agency announced on May 1 that it would defer enforcement of compliance deadlines regarding these products for three months, a move that the AAFP and several other organizations opposed in a May 17 letter(5 page PDF) to HHS. The organizations pointed out that the decision to extend FDA authority had been made over the course of several years and is based on sound evidence.
In the new letter, the AAFP pressed the FDA to maintain an aggressive stance regarding its authority to regulate such products.
"Every day of delay in its full implementation subjects the public to the continuing public health threat of unregulated, highly addictive and dangerous tobacco products, many of which come in sweet or candy flavors, which are designed and marketed to appeal to children," the AAFP wrote.
Another cause for concern is the agency's decision to delay by 18 months a requirement for updated nutrition labeling. The AAFP stated its strong objections to this decision an Oct. 16 letter(2 page PDF) calling for immediate enforcement, and pointed out in the recent letter that doing so would help address the obesity crisis.
"The extent of the problem demands immediate action, and this small but important step should be enforced now," the letter stated.
The AAFP also told the FDA that the agency should shift its focus regarding opioids away from a consideration to require prescriber training and instead find a way to build an effective state prescription drug monitoring database system. Family physicians do not need mandatory education to prescribe opioids.
"The AAFP opposes limiting patient access to any physician-prescribed pharmaceutical without cause, as well as any actions that limit physicians' ability to prescribe these products based on the physician's medical specialty," the letter stated.
Finally, the AAFP offered its full support for the FDA's mission to determine the safety and effectiveness of, and to regulate, drugs and devices based on solid evidence.