Guidance on Preventing Melamine Contamination For Pharmaceutical Industry

FDA Issues Pharmaceutical Industry Guidance on Preventing Melamine Contamination

In a guidance issued today, the U.S. Food and Drug Administration says that certain pharmaceutical ingredients used in the manufacture or preparation of drug products should be tested for melamine.

Melamine is a synthetic chemical with a variety of industrial uses including the production of resins and foams, cleaning products, fertilizers and pesticides. If ingested in sufficient amounts, melamine can result in kidney failure and death.

Although the FDA has no reason to believe that the U.S. pharmaceutical supply is contaminated with melamine, recent events involving pet and livestock food products in the United States, and milk products for infants in China, underscore the potential problem.

The guidance is an initial measure by the agency in working with pharmaceutical manufacturers, repackers, other suppliers and pharmacists to conduct melamine testing. The agency invites comments on the guidance, available online and titled "Guidance for Industry: Pharmaceutical Components At Risk for Melamine Contamination".

“The FDA urges implementation of appropriate controls to assure consumers that melamine contamination will not happen in the pharmaceutical supply chain,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “We look forward to working with industry on this serious public health concern.”

The FDA identifies specific pharmaceutical ingredients in the guidance that are recommended to be screened for the presence of melamine. The guidance also recommends the use of FDA-published methods for this testing that are used to detect the presence of melamine in food proteins. These tests rely on equipment that is generally available to pharmaceutical manufacturers or contract testing labs. The agency also is developing a sampling and testing program for pharmaceutical ingredients at risk for melamine contamination.

Comments may be submitted electronically at http://www.regulations.gov or by mail to FDA, Division of Dockets Management (HFA-305), 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with docket number FDA-2009-D-0354.

Tags: Pharmaceutical Industry, FDA, Melamine Contamination

Guidance for Industry, Drug-Induced Liver Injury

FDA has released a guidance to assist the pharmaceutical industry and other investigators who are conducting new drug development in assessing the potential for a drug or a product to cause severe liver injury (i.e., irreversible liver failure that is fatal or requires liver transplantation).

In particular, the guidance addresses how laboratory measurements that signal the potential for such drug-induced liver injury (DILI) can be obtained and evaluated during drug development.

This evaluation is important because most drugs that cause severe DILI do so infrequently; typical drug development databases with up to a few thousand subjects exposed to a new drug will not show any cases. Databases may, however, show evidence or signals of a drug’s potential for severe DILI if the clinical and laboratory data are properly evaluated for evidence of lesser injury that may not be severe, but may predict the ability to cause more severe injuries. This guidance describes an approach that can be used to distinguish signals of DILI that identify drugs likely to cause severe liver injury from signals that do not suggest such a potential. This guidance does not address issues of preclinical evaluation for signals of DILI, nor the detection and assessment of DILI after drug approval and marketing.
The guidance is available from FDA.
Follow the link below for a PDF file;
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM174090.pdf

Tags: drug-induced liver injury, DILI, drug development databases, FDA Guidance, pharmaceutical industry