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Inside This Issue Issue No. 225 FDA Counting on Global Strategy April 2011 To Better Secure Supply Chain The FDA’s work toward tighter supply chain control through INsIde thIs Issue international regulatory cooperation is falling short, but a new global strategy may speed up the agency’s progress, a top FDA Sterility issues lead to an- official says. other J&J recall ........Page 2 The next several years are critical in the agency’s transformation FDA zeroes in on compli- to a “global agency,” John Taylor, the FDA’s acting principal deputy ance history to make in- commissioner, said March 14 at a Pew Charitable Trusts conference spection decisions ....Page 3 in Washington, D.C., on drug supply safety. To achieve adequate supply chain control, Taylor said, the FDA 483 Insider ..............Page 5 needs novel and updated enforcement tools, a global alliance of reg- ulators, new authorities to create proactive tools for product safety, APP recalls oncologic irino- tecan over fungal contami- (See Global, Page 2) nation .......................Page 6 McNeil Gets Consent Decree After Pharma manufacturing in Period of Manufacturing Woes Japan largely spared by The FDA has said enough is enough to McNeil Consumer Health- quake ........................Page 8 care over its repeated manufacturing problems, issuing a consent decree that indefinitely closes one plant and places oversight over two others. Bill would increase penal- ties for prescription drug The agency said the Johnson & Johnson subsidiary, which has thefts ......................Page 10 been plagued with recalls of its OTC drugs relating to cGMP viola- tions, will not be able to reopen its troubled Fort Washington, Pa., Dakota labs gets warning plant until a litany of changes have been made. for GMP, labeling viola- The March 10 decree, filed in a Pennsylvania federal court, sets tions .......................Page 11 strict timeframes McNeil must meet or face fines, further recalls and additional shutdowns. Its also names as defendants McNeil’s vice GAO says FDA oversight is president of quality, Veronica Cruz, and Hakan Erdemir, the compa- at ‘high risk’ for misman- ny’s vice president of operations, for violating federal law by distrib- agement ..................Page 12 uting adulterated drugs. Pfizer recalls pain drug Em- Within 30 days of the decree, McNeil needs to outline its beda, prostate drug, antide- plans to destroy all lots of drugs in its possession or recalled since pressant ..................Page 14 (See McNeil, Page 4) Page 2 drug gmp report April 2011 Global, from Page 1 The agency must establish a review and audit infrastructure to verify that information and to adequate funding for inspections, examinations ensure that it can quickly take follow-up enforce- and sample collections and analysis, and updated ment action. systems, including IT support, to assist with increased workload. So far, the FDA’s adoption of new oversight strategies and its work with foreign partners has Moving forward, the agency will follow an not substantially increased coverage of its safety action plan with four primary components: activities, Taylor said. ● Partnering with foreign counterparts to Some programs are facilitating the shift create a global coalition of regulators; toward common safety standards, but the FDA ● Working to build a global data-information has only used these alternatives to its own stan- system and network, and proactively shar- dards in limited circumstances, he said. ing data with partners; ● Building additional intelligence-gathering “At the current rate of progress, and through the capabilities with an increased focus on current mechanisms, it would take decades to reach a risk analytics and a transformed IT capa- comprehensive set of common standards.” that would bility; and allow the FDA to leverage the work of third parties, ● Leveraging the efforts of public and pri- domestically and abroad, according to Taylor. vate sector third parties and industry to But working alone to ensure U.S. product safety, allocate FDA resources based on risk. the FDA’s efforts have sometimes fallen short, and foreign inspections still lag behind domestic inspec- Some of this work is already underway, but tions (DGR, November 2010). — April Hollis needs to be “taken to the next level,” Taylor said, including greater coordination and enforcement of regulatory standards across nations, even if Sterility Issues Lead to those standards are not identical. J&J Product Recall Regulatory authorities with greater experi- Another Johnson & Johnson (J&J) product ence and resources must work together to help is being recalled — the fifth recall in less than a build regulatory systems in countries with devel- month — amid sterility concerns. oping systems or fewer resources, he added. The latest recall follows the UK’s Medicines and The FDA will also enhance its intelligence- Healthcare Products Regulatory Agency (MHRA) gathering capabilities, with an increased focus issuance of a notice March 2, alerting British health- on risk analytics and IT capability. The agency care providers of the possible defect. The MHRA will create tools to quickly assess regulatory data says the packages may not have been completely across various information resources. sealed and the contents may not be sterile. “We must also create a modern means to The action involves 585,000 strands or 104 share data globally, and we must use those data batches of sutures sold under various names — and advanced analytics to proactively prevent Ethilon, Ethibond, Mersilene and Mersilk — by and identify problems,” Taylor said. J&J subsidiary Ethicon. The FDA will also develop programs in each The UK action follows an Ethicon recall last product type it regulates and in inspection pro- month of 700,000 vials of a liquid wound- grams within those categories, for approved pub- sealing product, Dermabond, amid reports of dis- lic and private third parties to conduct inspec- coloration and concerns it may take longer than tions and other oversight activities. expected to set (DGR, March). — David Pittman April 2011 drug gmp report Page 3 FDA Zeroes in on Compliance The agency recently joined the 37-member History for Inspection Decisions Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme, ATHENS, Ga. — Companies that have a and now has confidentiality agreements with 20 track record of non-compliance with GMPs countries. should come under greater FDA scrutiny and be more likely to get inspected, the FDA’s asso- The FDA also has foreign offices in China, ciate commissioner for regulatory affairs has India, Latin America and Europe, but Corrigan suggested. admitted there still needs more work in the area. Speaking March 15 at the International Good A GAO report last year also suggested Manufacturing Practices Conference, Dara Cor- improved coordination between the FDA’s overseas rigan said the FDA must “be able to shift our offices as well as long-term strategic planning. resources to the high-risk areas, which means the Overseas Inspections high-risks firms.” “There is a very current debate in FDA to fig- “We should be looking at those companies ure out whether we should actually place more with a history of non-compliance. They deserve people overseas versus having to fly them out,” more scrutiny, and they will have more scrutiny,” she said. she added. “And we are looking at ways to better track a company’s history over time.” A 2010 GAO report found that while on the rise, the number of inspections of foreign plants Warning Letter Increase pales in comparison to those done on domestic Corrigan didn’t elaborate on how the FDA facilities (DGR, November 2010). would handle or examine a company’s history, Corrigan, who began her government career but said there should be rewards for those compa- as a trial lawyer for the Justice Department in nies who meet or exceed standards. 1990, also addressed other pressing issues regard- “We need to have a way of looking at those ing her office. [companies] and really assessing where the risk About 40 percent of her department’s work is,” said Corrigan, who took office in Septem- force is comprised of new investigators hired in ber and oversees a field staff of roughly 4,000 the last three years. inspectors. “Good companies deserve FDA’s respect.” “A lot of these investigations and inspections are complicated, especially in drug manufactur- Corrigan noted a 42 percent increase in the ing,” she said. “It takes a while to get people up number of warning letters issued between fiscal to speed.” 2009 and 2010. She also said 68 percent of warn- ing letters from 2010 were issued within a four- In February, Deborah Autor, director of the month period. FDA’s Office of Compliance, said that a lack of resources to conduct foreign inspections is part However, Corrigan said warning letters aren’t of the reason why the agency has a huge backlog always a good metric for the amount or quality of of ANDA applications. compliance enforcement the FDA does. The FDA also needs people devoted to high- Corrigan acknowledged FDA Commissioner level drug inspections. Margaret Hamburg’s work to cooperate with foreign governments and inspectors to better “We’re creating a cadre of specially-trained ensure the quality of products made overseas and professional inspectors,” Corrigan said. shipped to the U.S. — David Pittman Page 4 drug gmp report April 2011 McNeil, from Page 1 As one recent example, the company in Janu- ary recalled nearly 43 million bottles of Tyle- December 2009, that were made at its Fort Wash- nol 8 Hour, Tylenol Arthritis Pain, Tylenol upper ington, Lancaster, Pa. and Las Piedras, Puerto respiratory products, Benadryl, Sudafed PE and Rico, facilities. Sinutab that were made at the Fort Washington, plant before it closed (DGR, February 11). The FDA also ordered McNeil to cease pro- duction at Fort Washington until it completes a The FDA issued McNeil a warning letter lengthy 10-step remediation process.
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