Pharmacists unaware they dispense unapproved drugs
Some 91% of retail pharmacists surveyed by Medical Marketing Research Inc., believe that all medications available for dispensing with a doctor's prescription have been FDA-approved, the researchers report. In fact, FDA estimates that as many as several thousand drug products are marketed illegally without required FDA approval.
The finding is part of a random sample survey of 500 retail pharmacists on their dispensing habits for drug products. Additional findings addressed pharmacists' understanding of a specific unapproved product — quinine sulfate. The researchers said that although the first FDA-approved formulation of quinine sulfate came onto the market in July, pharmacists continue dispensing formulations that have never undergone FDA evaluation.
The survey was sponsored by Mutual Pharmaceutical Co., Philadelphia, which has launched Qualaquin (quinine sulfate capsules 324 mg), the only formulation of quinine sulfate to be evaluated and approved by FDA. Qualaquin has been designated an orphan drug. Other survey findings include:
- 89% of those surveyed believe that all quinine sulfate products they dispense are FDA approved;
- 33% of pharmacists either do not know or do not believe that quinine sulfate has adverse events related to blood levels;
- 31% of pharmacists either do not know or do not believe that quinine sulfate has a specific, potentially life-threatening side effect of QT prolongation;
- 36% of pharmacists don't know that FDA specifically states that accumulation of quinine places the elderly at greater risk of adverse events.
Risk-based prioritized enforcement
A June 2006 guidance for FDA staff and industry, Marketed Unapproved Drugs — Compliance Policy Guide, describes how the agency intends to exercise enforcement discretion with regard to drugs marketed in the United States that do not have required FDA marketing approval.
For historical reasons, the guidance says, some drugs available in the United States lack required FDA marketing approval. Manufacturers of those drugs have not received FDA approval to legally market their drugs, nor are the drugs being marketed in accordance with the OTC drug review. Manufacturers of such drugs have not provided FDA with evidence demonstrating that their products are safe and effective, and thus the agency has an interest in taking steps to either encourage the manufacturers of the products to obtain the required evidence and comply with the approval provisions of the Federal Food, Drug, & Cosmetic Act or remove the products from the market. "We want to achieve these goals without adversely affecting public health, imposing undue burdens on consumers, or unnecessarily disrupting the market," the guidance said.
FDA estimates that as many as several thousand drug products are marketed illegally without required FDA approval in the United States today. "Because we do not have complete data on illegally marketed products, and because the universe of such products is constantly changing as products enter and leave the market, we first have to identify illegally marketed products before we can contemplate enforcement action," the guidance said. "Once an illegally marketed product is identified, taking enforcement action against the product would typically involve one or more of the following: requesting voluntary compliance; providing notice of action in a Federal Register notice; issuing an untitled letter; issuing a Warning Letter; or initiating a seizure, injunction, or other proceeding."
Because such enforcement actions are time-consuming and resource-intensive, FDA has prioritized enforcement efforts and exercised enforcement discretion. In recent years, the agency said, FDA has employed a risk-based enforcement approach for marketed unapproved drugs. That approach includes efforts to identify illegally marketed drugs, prioritization of those drugs according to potential public health concerns or other impacts on the public health, and subsequent regulatory follow-up.
Under the new guidance, FDA will give higher priority to enforcement actions involving unapproved drug products in these categories: drugs with potential safety risks, drugs that lack evidence of effectiveness, health fraud drugs, drugs that present direct challenges to the new drug approval and OTC drug monograph system, unapproved new drugs that also violate the act in other ways, and drugs that are reformulated to evade an FDA enforcement action.
[Editor's note: More information on the survey is available from Dan Budwick at (212) 477-9007. The FDA compliance policy guide is on-line at www.fda.gov/cder/guidance/6911fnl.pdf.]
Some 91% of retail pharmacists surveyed by Medical Marketing Research Inc., believe that all medications available for dispensing with a doctor's prescription have been FDA-approved, the researchers report. In fact, FDA estimates that as many as several thousand drug products are marketed illegally without required FDA approval.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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