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

UsernamePublicRestriction
UsernamePublicRestriction

FDA ISSUED 163 WARNING LETTERS TO DRUG FIRMS IN FIRST FOUR MONTHS OF NEW REGULATORY ACTION FORMAT, STEPPING UP PACE FROM EARLIER REGULATORY LETTERS

Executive Summary

FDA issued 163 warning letters to drug firms in the first four months of use of the new regulatory action format, according to FDA Office of Enforcement data through the end of the fiscal year (Sept. 30). Since switching in late May from the use of notice of adverse findings and regulatory letters, FDA has issued a total of 614 warning letters: 163 for drug regulation violations, 51 in biologics, 207 involving devices and radiation health, 121 in foods and 72 in veterinary medicine. Discussing the use of the warning letters at an Oct. 3 "Manufacturing and Controls" seminar sponsored by the Nonprescription Drug Manufacturers Association, FDA Office of Compliance Director Daniel Michels noted that the pace at which they are being issued "substantially" exceeds that for regulatory letters in the past. For instance, FDA issued a total of only 498 regulatory letters during all of fiscal 1990 and 370 in fiscal 1989. Michels noted that as of mid-September, 53 warning letters involving good manufacturing practice (GMP) violations had been issued; 20 of these to manufacturers of medical gases. Addressing industry concerns that the FDA field offices may be applying different standards in determining when to issue warning letters, Michels maintained that the districts are following FDA's stated policy in issuing them "only for violations of regulatory significance." Michels noted that there has been "discomfort on the part of the food and drug law bar as well as some quarters in the industry that we are going to be nickling and diming people using warning letters." However, he emphasized, "this is not the case. I have kept my ear to the ground in a number of locations," and "my sense is that the field is not miscuing very often," the compliance office director told the NDMA group. "When they are issuing these warning letters, they are for the right stuff and for serious violations." Michels advised firms that are "uncomfortable" with what's on an FD-483 inspection report or a warning letter to communicate that concern to the investigator on site or to the district office management. "Go back to the district director who signed the warning letter and work it out and make sure you are understanding," Michels suggested. If resolution is not possible there, he said, the next step would be to contact the Office of Compliance's Division of Drug Manufacturing and Product Quality. The problem should be brought to his personal attention or to the Ombudsman's office only if necessary, Michels said. If the firm agrees with the district management on the problems noted in the warning letter, Michels advised, "give the district management or the agency a timetable when you are going to get those things fixed."

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

UsernamePublicRestriction

Register

ID1128360

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

Cancel