FDA Reopens Public Comment on Behind-the-Counter Drugs

The FDA's behind-the-counter, or BTC, drug proposal has generated so much interest from physicians and pharmacists that the agency has reopened its public docket for comments on the issue until Dec. 17.

The FDA is exploring the public health benefit of allowing certain drugs now available by prescription only to be dispensed from behind the counter with pharmacist oversight. The original deadline for public comment on the program was Nov. 28, but according to FDA sources, the volume of information the agency had received -- including testimony at a Nov. 14 public meeting in Washington and written comments -- led to the decision to extend the deadline.

AAFP Board Chair Rick Kellerman, M.D., of Wichita, Kan., said the news of the extension was encouraging. "It's imperative that the FDA take a long, hard look at this issue, and I'm glad the agency is taking an appropriate amount of time to do so," he said. "Although the Academy respects the views of our pharmacist colleagues, we stand by our position that a patient's care should be coordinated by a physician."

Kellerman provided written comments to the FDA showcasing the Academy's opposition to the suggestion that pharmacists should be given the authority to dispense some drugs without the oversight of a physician and absent consultation between physicians and their patients.

AAFP Response to the FDA
In a Nov. 28 letter (6-page PDF file; About PDFs) to FDA Commissioner Andrew von Eschenbach, M.D., Kellerman said the background information presented on the proposal did not consider the effect the proposal would have on the "already fragmented American health (care) system and patient care."

"In our view, this plan is yet another symptom of a dysfunctional heath care system," said Kellerman, adding that the "perceived" inability of patients to get medications "should be addressed by overarching reform."

In its request for public comment, the FDA posed a list of questions, and Kellerman responded to those elements of the proposal that were relevant to physicians including:

Kellerman argued that the access issue would improve with the widespread adoption of patient-centered medical homes directed by primary care physicians. In addition, said Kellerman, patient compliance involves a mix of a patient's understanding of his or her disease as well as appropriate physician follow-up and monitoring.

Pharmacists are trained experts on drugs and their interactions, said Kellerman, but the Academy strongly opposes pharmacists performing roles such as disease diagnosis and monitoring and patient follow-up care. "These activities are the purview of the physician and not of the pharmacist," he said.

Kellerman also noted that patients with several chronic diseases who are taking multiple medications need a primary care physician trained to treat the whole person rather than an individual disease state. And in the event of a serious drug interaction, "patients should call their primary care physician and not a pharmacist," said Kellerman.

The AAFP also strongly opposes the suggestion that pharmacists receive reimbursement for the extra work that it would take them to dispense BTC drugs to patients. "Physicians are not paid appropriately for prescribing medications done in the context of diagnosis and treatment," said Kellerman. "Payment for dispensing of BTC drugs by individuals lacking physician knowledge and training would be an inappropriate use of scarce medical dollars."

Pharmacists Argue Their Viewpoint
Pharmacy groups have lined up in support of the FDA proposal. The American Pharmacists Association, or APhA, was among the more than 30 groups that sent representatives to the microphone at the Nov. 14 public meeting. (A complete transcript of the testimony delivered at that meeting is available on an FDA Web page dedicated to the BTC issue.)

The APhA and other pharmacy organizations argued that pharmacists are uniquely qualified to provide the necessary oversight for BTC drugs and are the medication-use experts on a patient's health care team.

Michael Moné, J.D., R.Ph., an APhA member and former appointee to its board of trustees, spoke on behalf of that organization (5-page PDF; About PDFs). He said pharmacists are a valuable and readily accessible resource to help meet patients' health care needs regarding access to the safe and appropriate use of medications. In addition, said Moné, pharmacists play a valuable role in patient self-care decisions, and BTC drugs would "increase patient access to medications, enhance patient education and improve medication use."

He also said the BTC proposal would succeed if, among other things, pharmacists were able to access patient medical information in a timely manner and were allowed, when appropriate, to provide follow-up patient monitoring. He argued in favor of pharmacists' right to bill and receive payment for the clinical services provided.

AMA Questions FDA's Authority
At the same meeting, the AMA testified that the FDA does not have the statutory authority to establish a BTC class and stated that there is no need for a new classification of drugs.

AMA testimony also supported the Academy's argument that interfering with the physician-patient relationship would negatively affect patient outcomes.