FDA Considers ‘Behind-The-Counter’ Drugs
Make a commentBy Ed Silverman // October 3rd, 2007 // 1:08 pm
The agency may establish a “behind-the-counter” system that could allow more prescription meds to be sold without customers actually having a prescription for them. In a Federal Register notice, the agency announced a Nov. 14 hearing on the issue. “The FDA is interested in obtaining public comment as it explores the public health benefit of drugs being available without a prescription but only after intervention by a pharmacist,” the agency said in an e-mail today.
Currently, most drugs are sold either with a prescription or OTC in retail stores and pharmacies. But the FDA has made a few exceptions. For instance, the agency limits distribution of Barr’s Plan B emergency-contraceptive pill to pharmacies that agreed to keep it behind the counter and require women show a photo ID to prove they are 18 or older. The FDA give permission to Barr last year to start selling Plan B without a prescription.
Some groups who have called for a behind-the-counter status for drugs have argued that it might allow certain meds sold with a prescription to be safely sold without one. The FDA noted that other countries with behind-the-counter status include Australia, Canada, New Zealand, Denmark, Germany, Italy, the Netherlands, Sweden and Switzerland. Along with a Nov. 14 meeting to solicit public comments on the issue, the FDA said it is also seeking written or electronic comments on the issue until Nov. 28.
In 2005, an FDA panel rejected a request by Merck and Johnson & Johnson to sell the Mevacor cholesterol pill without a prescription. Several panel members said the FDA should consider establishing a “behind-the-counter” system such as in the UK, where consumers can buy Merck’s Zocor. Most panel members said that, if such a system existed in the US, they would have voted to allow Mevacor to be sold without a prescription, Dow Jones reminds us.
The agency said it wants input on a variety of issues including whether there should be a behind-the-counter status for certain drugs, and whether the status should be a transitional way for prescription products to eventually move to over-the-counter status where consumers can purchase products on store shelves. Other questions include the impact on patient safety and whether it would improve patient access to medications.
The agency said certain logistical questions would need to be addressed including pharmacy storage and dispensing of the medications along with questions about whether and how pharmacists might be reimbursed for their time in dispensing drugs from behind-the-counter.