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CMAJ News For the record Published at www.cmaj.ca between Apr. The new warning letter regards in persistent or significant disability or 20 and May 18 breaches uncovered during a July– incapacity, be life-threatening or result August 2009 FDA inspection of an in death. Apotex receives second FDA Apotex facility located at 150 Signet The report indicates that there has Drive in Toronto, during which “sev- been a steady increase of adverse reac- warning eral violations that are identical” to tion reports since 2001, when roughly those found during the inspection of the 11 000 incidents were reported (www.hc he United States Food and Drug Etobicoke facility were discovered. -sc.gc.ca/dhp-mps/alt_formats/pdf/med Administration (FDA) has “These identical CGMP violations eff/bulletin/carn-bcei_v20n2-eng.pdf). T issued a second warning letter demonstrated a lack of adequate Roughly 70% (18 301) of 2009 inci- in a year to Toronto, Ontario-based process controls and raised serious dents involved pharamaceuticals, while generic drug manufacturer Apotex Inc. questions regarding your corporation’s 23% (5998) involved biotechnology for lapses in good manufacturing prac- quality and production systems,” the products. There were 833 adverse reac- tices. warning letter states. tion reports involving biologics, 516 The violations cause Apotex drug The violations included contamina- involving natural health products, 379 products to be considered “adulterated” tion of a diabetes drug with an “active involving radiopharmaceuticals and 34 within US regulations “in that the meth- pharmaceutical ingredient” and unspec- involving cells, tissues and organs. ods used in, or the facilities or controls ified “charred materials.” Other viola- Health Canada says that 8428 of the used for, their manufacture, processing, tions included contamination found adverse reaction reports were made by packing, or holding do not comform to, within an antihistamine, as well as fail- consumers and patients, while 6064 are not operated or administered in con- ure “to have an adequate equipment came from physicians, 4364 from other formity” with Current Good Manufac- cleaning and maintenance procedure or health professionals, 3853 from phar- turing Practice (CGMP), states the program to prevent contamination that macists, 2906 from nurses, 6 from den- FDA’s Mar. 29 letter to Apotex Inc. would alter the safety, identity, tists, 3 from naturopaths and 437 from President Jack M. Kay (http://www.fda strength, quality, or purity of the drug other unspecified persons. .gov/ICECI/EnforcementActions/Warn product beyond other established The report indicates that market ingLetters/ucm207508.htm). requirements.” authorization holders submitted 305 847 As a consequence, the FDA informed The FDA letter also states that the foreign adverse reaction reports in 2009, Kay that it would “recommend with- numerous violations cited “are not as compared with roughly 80 000 in holding approval of any new applica- intended to be an all-inclusive state- 2001. — Wayne Kondro, CMAJ tions or supplements listing your firm as ment of violations that exist at your a drug product manufacturer” until such facility.” AIDS funding promises time as corrective action is taken. Apotex did not respond to telephone “In addition, failure to correct these inquiries about the FDA warning letter. broken violations will result in FDA continuing — Wayne Kondro, CMAJ to deny entry of articles manufactured at ealthy nations are using the Apotex Inc., Toronto, Canada, into the Adverse reaction reports recent economic crisis to United States,” the warning letter added. W renege on promised AIDS The FDA had issued a similar warn- soaring relief, reports the International Treat- ing letter on June 25, 2009, with ment Preparedness Coalition, a world- respect to manufacturing breaches here was a 35% increase in wide advocacy group for people living uncovered at a Dec. 10–19 inspection domestic adverse reaction with HIV. of an Apotex facility in Etobicoke, T reports to the Canada Vigi- In the report Rationing Funds, Risk- Ontario. lance Program in 2009, Health Canada ing Lives: World Backtracks on HIV The latest FDA letter adds that while says in its annual report on the inci- Treatment, the coalition documents Apotex recalled about 659 batches of dence of adverse reactions. early warning signs resulting from the different products as a result of the Eto- The department received 27 496 global pull back on AIDS commitment bicoke inspection, there was evidence reports in 2009, of which 74.9% were and blasts major donors, such as the of “serious and repeat violations” and deemed to be serious enough as to Global Fund to Fight AIDS, Tuberculo- Apotex’s response to the manufacturing require in-patient hospitalization or sis and Malaria and the United States problems has been “inadequate and prolongation of existing hospitalization, President’s Emergency Plan for AIDS lacks sufficient corrective actions.” cause congenital malformation, result Relief (PEPFAR), for stalling or flat- CMAJ•JUNE 15, 2010 • 182(9) E421 © 2010 Canadian Medical Association or its licensors News lining promised funding (www.itpc 2007, only Botswana, Djibouti, and tml?id=/include/mpr_ndc_finder.inc), global.org/images/stories/doc/ITPC_M Rwanda had met that target. are distributed in Canada, the United TT8_FINAL.pdf). Private donations in the US and States, Dominican Republic, Dubai The report points to increasing caps Europe have also declined. Between (UAE), Fiji, Guam, Guatemala, on the number of people enrolled in 2007 and 2008, US-based philan- Jamaica, Puerto Rico, Panama, treatment programs, drug stock outs thropies decreased spending by about Trinidad & Tobago and Kuwait. and the frequency with which govern- 3%, while funding for European All of the products have been volun- ment-run antiretroviral treatment pro- HIV/AIDS charities dropped by 7%. tarily recalled by McNeil Consumer grams turn patients away at the door as The report tracks the fallout in six Healthcare “in consultation” with the the fallout of domestic and external nations: India, Kenya, Latvia, Malawi, FDA. funding cuts in the wake of the global Swaziland and Venezuela. It says con- “The FDA recommends that con- economic crisis. sequences include severely limited sumers stop using these products,” the “Providing access to AIDS treatment access to antiretroviral treatments, agency stated in announcing the recall for 4 million people has been the most shortages in physicians and nurses to (www.fda.gov/NewsEvents/Newsroom ambitious public health effort in his- provide treatment, and government /PressAnnouncements/ucm210441.htm). tory,” says the coalition board member reliance on outdated AIDS plans, as “As a precautionary measure, par- Gregg Gonsalves. “And after all this well as unreliable data on treatment ents and caregivers should not adminis- effort, we’ve got a few men in Wash- needs. ter these products to their children,” the ington [DC], in London [United King- “Nations with middle-sized FDA states. “Some of the products dom] and in Ottawa [Ontario] saying economies and considerable epidemics included in the recall may contain a maybe it’s time to do something else.” will be able to hold back the flood, but higher concentration of active ingredi- That’s the same as “saying to mil- the poorest countries are already being ent than specified; others contain inac- lions of people: drop dead. Without hit hard by this backtracking,” says tive ingredients that may not meet treatment that is certainly their fate,” Gonsalves. internal testing requirements; and oth- Gonsalves earlier stated in a media “If we don’t pay now, we’ll be pay- ers may contain tiny particles. While release. ing soon,” he adds. “Before the number the potential for serious medical events Created in 2001, the Global Fund of people in hospital beds goes up, is remote, FDA advises consumers who was intended to provide US$10 billion before we see a rise in funerals, the have purchased these recalled products per year to fight AIDS, tuberculosis damage will already be done.” to discontinue use.” and malaria. According to the report, Canada can play a major role in McNeil Consumer Healthcare stated that bold promise was not met; by shifting the trend if Stephen Harper can in a press release that the recall was a 2008, donations topped out at only $3 be convinced to make universal access “precautionary” measure (www.jnj billion per year (www.theglobalfund to treatment a priority at the next G8 .com/connect/news/all/McNeil-Consum .org/en/pressreleases/?pr=pr_100308). meeting, Gonsalves says. “Living south er-Healthcare-announces-voluntary-re The report criticizes US President of the border, we look to Canada for call-of-certain-OTC-infants-and-childrens Barack Obama and UK Prime Minister more progressive policies.” -products). Gordon Brown for failing to honor The report estimated that while “McNeil Consumer Healthcare is their country’s promises to donate a fair some 4 million people have access to initiating this voluntary recall because share toward the Global Fund. Obama HIV treatment, another 6 million peo- some of these products may not meet is also criticized for pledging US$50 ple still need it. — Lauren Vogel, required quality standards,” the com- billion to PEPFAR during his election Ottawa, Ont. pany stated in a press release. “This campaign, but then flat-lining funding recall is not being undertaken on the increases in 2010. basis of adverse medical events.” “I’m deeply disappointed in the Children’s health products The firm added that it is “conducting president, because the US has found recalled a comprehensive quality assessment money for bailouts and huge stimulus across its manufacturing operations and bills over the past 12 months, and what he United States Food and has identified corrective actions that we’re asking comes down to promises Drug Administration (FDA) is will be implemented before new manu- made and promises kept,” says Gon- T advising consumers to stop facturing is initiated at the plant where salves.

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