Washington Editor

WASHINGTON - The FDA is cracking down on unapproved drugs, which the agency conceded are surprisingly prevalent.

Its estimates point to several hundred different unapproved active ingredients in prescription drugs on the market, which represent less than 2 percent of prescribed drugs but nonetheless of enough concern to warrant a new guidance: "Marketed Unapproved Drugs - Compliance Policy Guide."

Such products have bypassed standard approval rules primarily because they were developed and marketed before successive changes to the drug approval process that is established in the Federal Food, Drug, and Cosmetic Act.

"The agency has significant public health concerns about marketed, unapproved prescription drugs," said Steven Galson, the director of the FDA's Center for Drug Evaluation and Research, noting that the products "may not meet modern standards for safety, effectiveness, quality and labeling."

But recommendations for them might be found in widely used pharmaceutical reference books or advertised in medical journals. In addition, their labels don't disclose that they lack FDA approval. The phenomenon is "in stark contrast to our current approach to drug safety," Galson said.

"Tackling this problem is integral to the comprehensive drug safety efforts that we've implemented at FDA over the past year," he added, later calling the matter "a significant and serious drug safety issue that must be addressed."

To highlight the problem, the agency singled out prescription products that include an antihistamine called carbinoxamine, which is contained in a pair of approved products for various allergic symptoms but found in many more without approval. Those products often are labeled for treating cough and cold symptoms, an indication for which the FDA has not found carbinoxamine safe and effective. Of particular concern are carbinoxamine-based products specifically labeled for use in children as young as 1 month, even though the compound never has been studied in very young children and their response cannot be predicted.

Galson said that the newly issued guidelines are meant to encourage companies marketing such products "to comply with the drug approval process and ensure the safety and efficacy of their marketed products."

Enforcement priorities will be given to unapproved drugs that pose safety risks, lack efficacy and constitute health fraud. Manufacturers that do not comply with drug approval requirements could be subject to enforcement action.

After Approval, Gardasil Awaits HHS Action

The FDA cleared the human papillomavirus vaccine Gardasil (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine) in females between 9 and 26, and next up is an HHS advisory committee scheduled to vote June 29 to determine whether the product should be regularly administered as part of a vaccine regimen in girls and young women.

Opponents to that proposal - principally those who contend that such use would increase teenage promiscuity - have been especially vocal since Gardasil received unanimous backing from an FDA advisory committee last month. But earlier this week, that opposition was countered by a Centers for Disease Control and Prevention employee, who in a speech here said that the product would not lead to an increase in teenage sex.

In addition, a survey publicized by the company behind Gardasil, Merck & Co. Inc., of Whitehouse Station, N.J., showed that up to 80 percent of 525 mothers with children as young as 11 would allow their daughters to receive a vaccine that helps protect against cervical cancer.

The FDA approval, which came Thursday, indicates Gardasil's use for preventing cervical cancer, cervical precancers, vulvar precancers and vaginal precancers caused by HPV types 16 and 18. It also is approved for the prevention of genital warts and low-grade cervical lesions caused by HPV types 6, 11, 16 and 18.

NIH Budget Could Plateau

It appears that the National Institutes of Health is destined for flat funding in the coming fiscal year, per a spending bill for the Department of Health and Human Services that received early approval this week by a House Appropriations subcommittee. While still a draft bill, it sets the NIH budget for next year at $28.3 billion, about the same as this year, but represents a cut when adjustments are taken for inflation. That has many watchers worried about reductions in research grants.

In another spending bill that includes funding for the FDA, an amendment that would have given the agency more power to mandate post-approval drug studies was removed by a House committee working on the agriculture spending bill. The same thing happened last year.

Bird Flu-Affected Family Quarantined

Members of an Indonesian family were quarantined and administered Tamiflu (oseltamivir, from F. Hoffmann-La Roche Ltd., of Basel, Switzerland) after six of their relatives died from human-to-human transmission of bird flu. A total of 54 people - surviving family members and others with close contact to those who died - were identified, isolated and dosed with the prophylactic treatment. As of earlier this week, there had been no new cases suggestive of H5N1 infection among those under quarantine or elsewhere in the village, which has about 400 households. Therefore, the World Health Organization has not found evidence that the virus is spreading in an efficient and sustained manner from one person to another and has not elevated its alert. More recently, Indonesian government authorities confirmed the country's 49th case of human H5N1 infection.

Personalized Breast Cancer Study Launched

The National Cancer Institute in Washington is sponsoring a newly launched study to determine whether genes that are frequently associated with risk of recurrence for women with early stage breast cancer can be used to assign patients to the most appropriate and effective treatment. It will do so by incorporating a molecular profiling test called Oncotype DX, which was developed by Genomic Health Inc. in Redwood City, Calif., into the clinical decision-making process. The study will enroll more than 10,000 women throughout the U.S. and Canada. Eligibility requirements include recent diagnoses with estrogen receptor and/or progesterone receptor positive, Her2/neu negative breast cancer that has yet to spread to the lymph nodes. It is being coordinated by the Eastern Cooperative Oncology Group.

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