New drug initiatives, task force report announced

The federal government announced several new initiatives recently regarding prescription drugs, as well as the final report from the Counterfeit Drug Task Force:

• The final report from the U.S. Food and Drug Administration’s (FDA’s) Counterfeit Drug Task Force:

The task force, created in July 2003, met with and heard from security experts, federal and state law enforcement officials, technology developers, manufacturers, wholesalers, retailers, consumer groups, and the general public. In October 2003, the task force issued an interim report that was followed by a public meeting and technology forum where 72 presentations were made.

The report describes specific steps that can be taken now and in the future to protect consumers from counterfeit drugs and to secure the U.S. drug distribution system. Some of these measures include:

  • Implementation of new technologies to better protect legitimate drugs against tampering or replacement with counterfeits.
  • Adoption of reliable modern track and trace technology, which the FDA has concluded is feasible by 2007, to accomplish and surpass the goals of the Prescription Drug Marketing Act.
  • Adoption and enforcement of stronger anti-counterfeiting measures by the state regulators of drug wholesalers and distributors.

The full FDA Counterfeit Drug Task Force Final Report, including more recommendations, can be found at www.fda.gov/oc/initiatives/counterfeit/.

• The Department of Health and Human Services (HHS) has created a task force to advise and assist HHS in determining how drug importation might be conducted safely and its potential impact, positive and negative, on the health of American patients, medical costs, and the development of new medicines.

The task force intends to convene five meetings, one each with representatives from the following groups: consumer groups; professional health care groups; health care purchasers, including representatives of cities and states; industry associations; and international stakeholders. There also will be a meeting for the general public to provide comments.

The task force will also open a public docket to accept comments. To begin public discussion, the task force will post a set of preliminary questions about the safety and impact of drug importation. The task force will publish proceedings from the stakeholder meetings.

• The FDA has launched a new web site to help consumers and health professionals find information about FDA-approved drug products. The new interface, Drugs @ FDA, is a searchable database that includes information on approved prescription drugs, some over-the-counter drugs, and discontinued drugs. Located on the web page of the FDA’s Center for Drug Evaluation and Research (CDER), it is the first web resource to offer a comprehensive overview of a drug product’s approval history.

The database incorporates information from all parts of CDER’s web site, including Consumer Information Sheets, Medication Guides, labeling, and other information for patients. Eventually, information on recalls, warnings, and drug shortages will also be included.

Users can search by drug name or active ingredient to retrieve a complete approval history and accompanying documents for a particular drug product. Users also can find out if therapeutic equivalents exist, including generics for brand name drugs.