Regulatory news

December 1, 2005
Pharmaceutical Technology Editors

Pharmaceutical Technology Europe

Pharmaceutical Technology Europe, Pharmaceutical Technology Europe-12-01-2005, Volume 17, Issue 12

The introduction of new measures on advertising and promotional materials for prescription medicines could delay UK launches. The Medicines and Healthcare products Regulatory Agency (MHRA) has admitted that the checks, which have been introduced in response to a Commons' Health Select Committee report, could extend a launch by at least 2 weeks.

Advertising checks delay UK launches

New measures will tighten promotional requirements

The introduction of new measures on advertising and promotional materials for prescription medicines could delay UK launches. The Medicines and Healthcare products Regulatory Agency (MHRA) has admitted that the checks, which have been introduced in response to a Commons' Health Select Committee report, could extend a launch by at least 2 weeks.

The report conducted by the committee of MPs was highly critical of the MHRA and the industry, finding that existing measures were not preventing companies from making inflated or misleading claims.

Under the new measures all new products will be vetted by MHRA staff prior to launch, which is expected to take 3–6 months unless problems are identified. To ensure that the length of the vetting process is minimized it will be performed at the same time as the licensing procedures.

Despite several industry representatives voicing concerns over the delays, MHRA is adamant in adopting stricter guidelines on advertising. These changes in the rules coincide with the release of MHRA's publication Blue Guide Advertising and Promotion of Medicines in the UK.

www.mhra.gov.uk

Companies warned over hormone therapies

Action has been taken by FDA and the Federal Trade Commission (FTC) against several marketers of unapproved 'alternative hormone therapies'. FDA warning letters have been issued to 16 dietary supplement and hormone cream marketers that have made unverified claims about the benefits of the products. Thirty-four letters have been issued by FTC to websites promoting 'alternative hormone therapies' that also claim advantages without sufficient evidence.

The therapies in question have been unapproved because they were found to be unsafe and were not effective in treating or preventing certain serious or life-threatening diseases, such as cancer, heart disease and osteoporosis.

FDA considers a product to be a drug if it claims to diagnose, cure, mitigate, treat or prevent disease under the federal Food, Drug and Cosmetic Act. The warning letters state that the new drugs require FDA approval before marketing and it specifies that the advertising claims are governed by the FTC Act.

The marketers that have been issued with FDA warning letters must respond within 15 days.

www.fda.gov

FDA loses 4-year dispute

The courtroom dispute over quality system regulation (QSR) requirements has been concluded in a monumental decision against FDA. The long legal battle involving Utah Medical has implications for other medical device and pharmaceutical companies that are FDA-regulated.

The case was dismissed after the court disagreed with FDA's allegations that Utah Medical was non-compliant with the agency's interpretation of the QSR. The medical device company was not given the interpretation of the requirements until after the lawsuit had been filed for the closure of the Utah facility.

The court ruled that the QSR of the company's products were not in question and that there was no evidence of them being unsafe, ineffective, defective or harmful to patients.

FDA's regulations were criticized by the federal judge who stated that they had the virtue of generality and the vice of imprecision.

www.utahmed.com

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