In the Field: News - Pharmaceutical Technology

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In the Field: News

Pharmaceutical Technology
Volume 3, Issue 32

Zone in on: REGULATION

FDA to Allow Off-Label Information
by Angie Drakulich

The US Food and Drug Administration issued a draft guidance Feb. 15 on "Good Reprint Practices" regarding the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices.

"Articles that discuss unapproved uses of FDA-approved drugs and devices can contribute to the practice of medicine and may even constitute a medically recognized standard of care," said Randall Lutter, FDA deputy commissioner for policy, in an agency release.

Industry has been asking for clarification of "off-label" use and promotion since late September, when Section 401 of the Food and Drug Administration Modernization Act expired. Section 401 provided guidelines allowing the dissemination of information on unapproved uses of FDA-approved products.

While the new draft guidance answers this call, some individuals claim the language may be too simple, and that it has been released too quickly. Rep. Harry Waxman (D-CA), chairman of the House Oversight Committee, wrote FDA Commissioner Andrew von Eschenbach twice in the past few months, questioning the way in which the agency was pursuing the guidance. He said he had "significant concern" about the guidance proposal as it would "allow drug and device companies to use journal articles to promote potentially dangerous uses of drugs and medical devices without prior FDA review and approval." Rep. Waxman and others also speculated that industry representatives have been pushing the agency to release the guidance, according to several media reports.

Rep. Waxman has said that the rule would give pharmaceutical companies too much leeway with off-label use and marketing. Compared to Section 401, the draft guidance seems to allow for easier dissemination of articles on unapproved uses of drugs and may encourage companies to carry out fewer clinical studies. The draft guidance gives manufacturers just a few principles to follow when distributing scientific or medical journal reprints, articles, or reference publications. For example, the draft calls for manufacturers to ensure that the article or reference be published by an organization that has an editorial board, and disclose any conflicts of interest for all authors or contributors to the article. In addition, articles should be peer-reviewed and published in accordance with specific procedures such as with a bibliography, but without any highlighting by the manufacturer.

The draft guidance does warn against distribution of special supplements or publications "that have been funded by one or more of the manufacturers of the product in the article," as well as against articles that are "not supported by credible medical evidence."

Public comments on the draft guidance are due Apr. 21.


Recalled Ingredient Made in China
by Susan Haigney

The US Food and Drug Administration revealed in mid-February that the active ingredient used in the production of Baxter International's (Deerfield, Illinois) recalled drug heparin was made in a plant in China. At press time, it was not known whether the ingredient played a role in the approximately 350 adverse reactions and four deaths possibly caused by the blood thinner. The possible involvement of a Chinese factory in the production of a recalled drug, does however, renew concerns regarding Chinese-made products.

According to the Wall Street Journal, China is the "world's largest producer of active pharmaceutical ingredients" and FDA admits it had not inspected the particular Chinese plant due to a mistake in paperwork (plans for an inspection were immediately made by FDA). Critics say that the failure of FDA to inspect foreign manufacturing facilities continues to put consumers and patients at risk. A Baxter spokesperson told the WSJ that the company has had a 20-year relationship with the Chinese supplier and that the supplier has made the specific active ingredient for 30 years. According to the spokesperson, no changes were recently made at the Chinese plant. Baxter temporarily halted production of heparin in February after reports of four patient deaths and allergic reactions that included stomach pain, vomiting, low blood pressure, fast heart rate, and fainting. Baxter is a major producer of heparin, providing half of the nation's supply. APP Pharmaceuticals (Schaumburg, Illinois) acquires the active ingredient for its heparin blood thinner from a Chinese plant as well but has, reportedly, not experienced the same adverse effects.

A recent interview with Prof. Michael Santoro at Rutgers Business School discussed whether the pharmaceutical industry should "get out" of China. Do you think industry, or Congress, should cut commercial ties with China for the time being? Email

Susan Haigney is coordinating editor of the Institute of Validation Technology journals.


Industry Perspectives

"Our industry is small and people move around. Even when a project ends, you will see the same people again, sometimes on a different project with a different company. As such, it's important to form good working relationships with people, not just companies."

Charles Younger, PhD, Director of Project Management, Quotations, Finance and Systems, Pharmaceutical Development Services–Canada, Patheon, 2007 AAPS Conference


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