February is whizzing by. Thankfully, we got through Valentine's Day (bah, humbug). A bill actually got through Congress. Some members of Congress and some party officials have provided quite a bit of humor through their antics and utterances, entirely without intention. The wind is blustery here in Washington, literally and figuratively. The great peanut recall drones on and on and on….
In the meantime, here is a little bit from our world:
- European Medicines Agency Recommends Suspension of Marketing Authorization for Raptiva® – Merck Serono announced that the EMEA is recommending the suspension of the treatment for psoriasis. The reason for the recommendation is the discovery of cases of progressive multifocal leukoencephalopathy (PML) in psoriasis patients treated with Raptiva®. In the U.S., the FDA this week issued a warning about the PML cases. Two of the three cases occurred in the U.S. and were reported by Genentech, which is the U.S. marketer of Raptiva. The fact that the EMEA acted to have the drug withdrawn from Europe before the FDA responded with an alert saying that they are looking into the issue of whether the risks outweigh the benefits, is going to be more grist for the mill for Congressional critics of the FDA in the U.S.
- Cardinal Health 303, Inc. Signs Amended Consent Decree with FDA – This FDA press release is a nice overview of how Consent Decrees come about and work - The U.S. Food and Drug Administration announced today that California device
manufacturer Cardinal Health 303 Inc., formerly known as Alaris Medical Systems
Inc., and three of its top executives have signed an amended consent decree to
correct violations of current Good Manufacturing Practice (cGMP) requirements in
the company's infusion pumps. Infusion pumps are devices intended for controlled delivery of intravenous
solutions and medications to patients. Under the terms of the amended consent decree, Cardinal 303 agrees to comply
with the cGMP requirements and Quality System (QS) regulations in the designing,
manufacturing, processing, packing, repacking, labeling, holding or distributing
of its infusion pumps. Cardinal 303 also must retain an independent expert
consultant to inspect of all of its infusion pump facilities and recall
procedures, and certify to the FDA that corrections have been made.
Additionally, the company must submit to the FDA a detailed corrective action
plan to bring all infusion pumps currently in use in the United States into
compliance with the Federal Food, Drug, and Cosmetic Act (FDCA). The decree covers all of the company's infusion pumps, including the Alaris
System (formerly known as Medley) infusion pump, the Gemini infusion pump and
the Med System III infusion pump. In August 2006, U.S. Marshals seized certain models of Cardinal 303's Alaris
SE (formerly known as the Signature Edition) line of infusion pumps at the
company's manufacturing facility in San Diego, Calif. Subsequently, in 2007,
Cardinal 303 signed a consent decree in which they agreed to cease
manufacturing, processing or distributing the Alaris SE line of infusion pumps
until the company corrected deviations from the QS regulations. Cardinal 303 is
still in the process of making these corrections. After the company signed the consent decree related to the SE line, FDA
investigators found similar QS deviations relating to another line of Cardinal
303's infusion pumps. Among the deficiencies was a failure to notify the FDA in
a timely manner after becoming aware that one of the company's infusion pumps
had malfunctioned and that the device would be likely to cause or contribute to
death or serious injury if the malfunction were to recur. Cardinal 303 also
failed to establish and maintain procedures to review, evaluate, and investigate
complaints of malfunction or failure of its pumps. Based on these violations,
the FDA sought to amend the 2007 decree to cover all of Cardinal 303's infusion
pumps. Once Cardinal 303 makes the corrective actions specified in the decree, the
company must hire an independent auditor to conduct annual audit inspections of
all of its infusion pump facilities for at least four years and report the
results to the FDA. The amended consent decree also authorizes the FDA, in the event of future
violations, to order Cardinal 303 to cease manufacturing and distributing, to
recall products, and to take other actions. The defendants may be required to
pay damages of $15,000 per day if they fail to comply with any provisions of the
decree, plus an additional $15,000 for each violation, up to $15 million per
year. - Chairmen Waxman and Stupak Request Study Data for Vytorin - Chairman Waxman and Subcommittee on Oversight and
Investigations Chairman Stupak wrote to Schering-Plough and Merck, the companies
developing Vytorin, to request further information regarding two studies on the
drug. The monitoring boards for the studies released their data to
Schering-Plough and Merck before the conclusion of the studies upon the request
of those companies.
That's it for me this week. Have a good weekend everyone.
