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

FDA HUMAN DRUGS & BIOLOGICS PROGRAMS WILL RECEIVE $3.5 MIL. MORE in fiscal 1988 than the $150.4 mil. appropriated in fiscal 1987. The additional $3.5 mil. is provided in the continuing appropriations resolution (HJ Res. 395), which Congress passed on Dec. 22. The agency had requested a $10 mil. increase over 1987 appropriations. Under the continuing resolution, fiscal 1988 appropriations would total $4.5 mil. for orphan products programs, an increase of $500,000 over the previous year's funding. The 1988 appropriations also increase spending limits by $1 mil. for the National Center for Toxicological Research, and by $2 mil. for medical device programs. The total 1988 appropriation for FDA salaries and expenses is $450.5 mil. The figure, which was proposed by the House, is less than the $456.2 mil. in appropriations proposed by the agency and the $454.1 mil. proposed by the Senate. Congress appropriated $423.8 mil. for FDA salaries and expenses in fiscal 1987. Congress also added $8.9 mil. to fiscal 1987 funding levels for FDA's efforts against AIDS. With the increase, FDA's 1988 appropriations for AIDS programs totals $24.8 mil., $200,000 more than the agency requested. The increase in AIDS program funding comes as FDA is stepping up its efforts to combat the disease. At a Dec. 15 session of the Food & Drug Law Institute's annual meeting, Commissioner Young announced that the agency is creating two new product review divisions to focus on evaluation of AIDS therapies. An Antiviral Drugs Division will be established under the Center for Drug Evaluation & Research, and the Cytokine Biology Division will operate under the Center for Biologic Evaluation & Research ("The Pink Sheet" Dec. 21, p. 3).

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

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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