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Pharmaceutical Technology


ADVOCACY

Medical Students Oppose Big Pharma's Influence on Campus

Medical students in Reston, Virginia, participated in various activities in late October to persuade medical schools to shield their campuses from the influence of pharmaceutical marketing. The activities are part of "National PharmFree Week," an event sponsored by the American Medical Student Association (AMSA PharmFree Scorecard Results|~www.amsa.org/prof/scorecard07.pdf). On Oct. 22, AMSA, the National Physicians' Alliance, and the Prescription Project lobbied in support of Senate Bill S.2029 on Capitol Hill. The legislation would require pharmaceutical companies to provide regular public reports of payments (including trips, honoraria, and entertainment) they make to physicians. The bill would also impose a fine on companies that fail to file reports.

The University of Illinois at Chicago held a "FLIP Symposium" on Oct. 27 to provide medical students with skills to help them use critical thinking and examine evidence when prescribing medicines. Catherine DeAngelis, editor-in-chief of the Journal of the American Medical Association (JAMA), was a guest speaker at the event. According to JAMA, roughly 90% of the pharmaceutical industry's $21-billion marketing budget is directed at physicians. More than 90,000 pharmaceutical representatives visit US physicians and medical students, offering free lunches, gifts, promotional materials, and medication samples. The visits and gifts are intended to influence doctors' prescribing habits.

"These marketing practices, including the growing number of 'ask your doctor' commercials, has led to overmedicating the US population," says Michael Ehlert, AMSA's national president. "By eradicating pharmaceutical marketing from all medical schools, hospitals, and academic medical centers, physicians will be able to go back to practicing evidence-based medicine," he added.

Earlier this year, AMSA released its PharmFree Scorecard, which ranks medical schools according to their pharmaceutical policies. AMSA is a student-governed, nonprofit organization founded in 1950 to represent medical students' concerns. The group started its first PharmFree Campaign in 2002 to teach medical students to interact ethically with the pharmaceutical industry.

-Erik Greb

REGULATION

FDA Revises Postmarketing Reporting Requirements




Under a new US Food and Drug Administration revision, sole manufacturers of drugs considered life-supporting or life-sustaining or that prevent certain serious diseases or conditions will be required to notify FDA at least six months before discontinuing production of the product.

The revision applies to a proposed rule announced Nov. 7 to implement section 506(c) of the Federal Food, Drug, and Cosmetic Act. This rule applied to companies that are the sole manufacturers of drugs that meet the following criteria:

  • The products are life-supporting, life-sustaining, or intended to prevent a debilitating disease or condition
  • The products must have been approved under section 505(b) or (j) of the Act [21 USC 355(b) or (j)]
  • The products are not originally derived from human tissue and replaced by a recombinant product.

The amended, final rule modifies the reporting procedure for these drugs whether regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). Manufacturers are required to send notifications of discontinuance or requests for reduction to the following offices:

  • The drug-shortage coordinator at the address of Director of CDER
  • The Drug Registration and Listing Team, Division of Compliance Risk Management in CDER
  • The director in the review division in CDER or CBER who is responsible for reviewing the application.

The proposed requirement to notify the Director of CBER was eliminated. Under certain circumstances, including economic hardship and public-health risks, the six-month notification period may be reduced.

FDA announced the amendment in the Oct. 18 issue of the Federal Register; the final rule will take effect 60 days after this date.

-Maribel Rios


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