Drug & Device News

GAO Finds FDA's Safety Tracking System Lacking

A report issued in December by the Government Accountability Office (GAO) (available at: http://1.usa.gov/1QpJXmc), faults the U.S. Food and Drug Administration's (FDA's) management of postmarket drug safety information. The FDA is supposed to keep track of postmarket studies and other data concerning safety problems with FDA-approved medications that have entered the market, but its current systems are apparently inadequate for this purpose. According to the report, “Internal control standards for federal agencies specify that information should be recorded in a form and within a time frame that enables staff to carry out their responsibilities and that relevant, reliable, and timely information should be available for external reporting purposes. However, evaluations conducted by CDER (Center for Druge Evaluation) of data in its database revealed problems with the completeness, timeliness, and accuracy of the data.” Because of these inadequate systems, data is not being recorded and made accessible in a way that would allow the FDA to publish statutorily required reports on potential drug safety issues.

The report says that the FDA agrees with the GAO's findings and is working to improve its systems to address the GAO's concerns.

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New York Goes Paperless

On March 27, New York became the first state to require all prescriptions to be electronically submitted directly from the prescriber to the pharmacy. It is hoped that the change in method will decrease the incidence of misread prescriptions and, more importantly, cut down on sales of prescriptions on the black market and eliminate the risk of a patient's modifying a prescription (by, for example, writing in a higher number of pills to be dispensed). The new method of prescribing will not be without its problems, of course. Patients will need to know which pharmacy they will use before the prescription may be written, so they will not be able to shop around for stores with better prices. If a patient decides later that he would prefer to use a different pharmacy ' perhaps because of high prices or unavailability of the medication at the designated pharmacy ' the prescriber will have to cancel the original order and write a new prescription.

Certain types of prescriptions are exempt from the new law, such as those that the patient intends to fill out of state, or those written for equipment, like a wheelchair. Prescribers who fail to follow the new law may be subject to both civil and criminal sanctions.

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Amarin Negotiates Right to Promote Off-Label Drug Uses

The FDA has agreed to permit pharmaceuticals manufacturer Amarin Corporation to promote its drug Vascepa to patients with less severely high levels of triglycerides (a fat in the blood that is a marker for possible heart disease) than was previously allowed. The FDA has only officially approved the drug for those people with the highest levels of triglycerides, but the drug manufacturer sued the agency last year for a declaration that it could promote Vascepa to a larger patient population. A federal judge sided with Amarin, concluding that as long as it did not lie to or mislead prescribers or consumers, the company had the Constitutional right to speak freely to them. The settlement followed. It will require the drug manufacturer to submit its promotional materials to the FDA for approval. If the parties cannot come to agreement on them, the court will step in to decide any issues. Amarin's president and chief executive officer John F. Thero, said in a statement following the settlement: “With more truthful and non-misleading information readily available to healthcare professionals about the potential of Vascepa to improve cardiovascular health, this settlement serves the public interest by supporting informed medical decisions for tens of millions of patients with persistent high triglycerides.” Some see the case as an opening for other pharmaceuticals companies to promote their own drugs for off-label uses, something the FDA has in recent years cracked down upon, forcing many companies to pay high fines for making claims similar to Amarin's.

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