FDA, EU consider joint inspections program
WASHINGTON A pilot program is under discussion between the Food and Drug Administration and the European Union with the intent of using one auditor to conduct facility inspections on behalf of both jurisdictions.
The FDA, in order to facilitate such inspections, recently released a final Global Harmonization Task Force guidance on audit reports prepared on behalf of regulatory agencies.
The FDA and Health Canada currently have a similar arrangement, Pilot MultiPurpose Audit Program, in which a third-party auditor inspects a facility on behalf of both. “We have this pilot program in Canada where it’s one auditor doing [International Standards Organization] and quality system audits at the same time,” said Tim Ulatowski, Center for Devices and Radiological Health director of compliance, according to published reports. “We’ve had a number of successful audits right now that have occurred [and now] the EU wants to join in that pilot.”
The FDA guidance document, “Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 3: Regulatory Audit Reports,” is intended to promote uniformity and assist auditors in the preparation of more universal reports.
Despite clinic closings, Meijer keeps commitment to health care
GRAND RAPIDS, Mich. Meijer has had a growing retail clinic program that helped establish its positions as a retailer interested in the needs of consumers hard pressed by medical costs, while also offering a free prescription drug program that provides antibiotics to customers free of charge, further marking its commitment.
The Meijer commitment remains, as does the prescription drug program, but most of the clinics are gone, although through no fault of the retailer.
Meijer has gone from having 39 clinics operating in its stores to having one unit that is situated in Normal, Ill. The company leased space to four different providers who operated independently, but in recent weeks, three of the four have withdrawn from the market, and, as a result, clinic operators who had opened units in Meijer stores in upper Michigan, the Detroit area and Indiana have shuttered their operations.
Family Quick Care operates the Normal clinic, and a Meijer source noted that it seems to be doing well. Physicians Organization of Western Michigan, Early Solutions and Medical Mart operated the defunct clinics.
New chief executive officer at Lilly stresses drug development
INDIANAPOLIS John Lechleiter, a Harvard-trained chemist, has been named Eli Lilly’s chief executive officer beginning on April 1, according to published reports. He will be succeeding Sidney Taurel who has announced his retirement from the Fortune 500 company.
Lechleiter will be the ninth leader in the company’s 131 years, and make a salary of $1.4 million, with a possible bonus of $2 million depending on the company’s performance, according to published reports.
A new leader seems to be a positive change for the company as its best-selling drug Zyprexa, an anti-psychotic, will lose its patent protection in three years, and its other top-selling drugs Cymbalta, Gemzar and Humalong, will expire two years after, further increasing the company’s pressure to introduce new products to the market.
According to the new chief executive officer, the introduction of new drugs will be his main priority, and is optimistic in this development. “As many challenges as we have in this industry today, it’s also a time of tremendous opportunity when you look at how much more we know about the human biology that underlies the mechanisms of disease,” said Lechleiter.