FDA suspends GMP requirements on trial drugs

July 23, 2008

The FDA has issued new guidelines that exempt Phase I drugs from certain Good Manufacturing Practice regulations.

In issuing the exemptions–which go into effect September 15, the agency notes that GMP regulations were designed more for commercial manufacturing than for investigational products designed for a Phase I trial.

FDA News notes that Phase I products will no longer have to meet GMP requirements for “a fully validated manufacturing process, rotation of stock for drug product containers, repackaging and relabeling of drugs and separate packaging and production areas.”

“FDA’s position is that the United States’ [GMP] regulations were written primarily to address commercial manufacturing and do not consider the differences between early clinical supply manufacture and commercial manufacture,” the agency says.

In connection with the final rule on Phase I drug GMPs, the FDA issued a guidance recommending approaches to satisfy statutory GMP requirements for such drugs.

More information on the final rule can be accessed at www.fda.gov/OHRMS/DOCKETS/98fr/oc07114.pdf. A copy of the guidance, “CGMP for Phase 1 Investigational Drugs,” can be viewed at www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2005-D-0157-gdl.pdf.

IAC Commends the U.S. Congress for Passing the Medicare Improvements for Patients and Providers Act

July 23, 2008

Medicare Bill Supports Quality Patient Care through Imaging Accreditation Requirements

The Intersocietal Accreditation Commission (IAC) is pleased to acknowledge that on July 9, 2008, the U.S. Senate passed the Medicare Improvements for Patients and Providers Act of 2008 (H.R. 6331).

What Bill requires

The bill requires that by 2012, providers of advanced diagnostic imaging services, inclusive of Nuclear Medicine, MR, CT, and PET, must obtain accreditation as a condition for reimbursement. In addition, it establishes a two year voluntary program to collect data regarding physician compliance with appropriateness criteria in order to determine the appropriateness of advanced diagnostic imaging services furnished to Medicare beneficiaries.

The portion of the legislation requiring accreditation stipulates that the accreditation programs must evaluate that physicians and staff maintain the proper level of training and education; that laboratories use imaging equipment which adheres to strict standards of performance and operates under proper safety guidelines; and that all laboratories establish and maintain a quality assurance program, thereby upholding the standards of quality care for patients, particularly senior citizens.