Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Executive Summary

HOME AIDS TEST KITS SHOULD BE AVAILABLE OVER THE COUNTER "without any restrictions requiring professional medical use," FDA Blood Products Advisory Committee member Ross Eckert, PhD, Claremont McKenna College, maintained in recent comments to the agency. FDA's current policy requires that home AIDS tests be labeled for professional use "for reasons of blood safety, confidentiality and cost." Maintaining that "concerns over blood safety should dominate counseling," Eckert said that "if HIV home test kits are restricted to professional use only, then people who want to be tested but who do not want to go (or cannot afford to go) to professionals may attempt to go to blood banks to be tested. We know that high-risk persons still succeed in donating blood and that the screening procedures in place in some blood banks are inadequate." FDA currently is formulating a final policy on home AIDS testing and has solicited comments from interested parties. On April 6, the agency held an open public hearing on home AIDS testing. At the hearing, several public health officials said they were reluctant to make the kits OTC because of concerns over the availability of counseling, proper specimen collection and maintenance of confidentiality. Eckert said that he is in favor of allowing unrestricted marketing of home HIV tests "even if zero counseling were provided." However, he suggested that requiring telephone counseling "would be a sensible compromise." He pointed out that over-the-phone counseling currently is available for crises such as suicidal tendencies, accidental poisoning and heart attacks and argued that "telephone counseling by persons who provide these services regularly would on the average be superior to counseling in person by physicians who do it rarely." Concerns about proper collection should also not prevent the marketing of home AIDS tests, Eckert maintained. "If manufacturers of HIV home test kits cannot satisfactorily explain to people how to prepare and package blood samples, and if they cannot be shipped in a manner that will produce valid test results, then manufacturers will not make long-run profits from such kits. Thousands of other blood samples are successfully shipped every day. It is difficult to believe that this is a serious objection to home testing." FDA will accept comments on its home AIDS testing policy until May 5. The agency says it will consider all opinions in formulating a definite policy on the products.

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts