Press report targets pharma QC in Puerto Rico


By George Miller

Puerto Rican industry officials report little impact from an early February press report that implied sub-par quality control practices among the island’s drug makers.

“Fortunately, the pharmaceutical industry knows Puerto Rico well, knows its track record in quality compliance,” says Enrique Mirandes, director for the life sciences business unit of the government-owned Puerto Rico Industry Development Co. (PRIDCO) in Hato Rey.

He described “indignation” as the reaction from local pharmaceutical executives–those truly responsible, of course, for the quality control practices within their respective facilities.

“For every one of those isolated cases,” says Mirandes, “there are dozens of examples of facilities that have consistently achieved the highest levels of compliance.” The contamination incidents cited occurred in three out of more than 60 plants on the island. “Statistically, these are almost insignificant,” says Mirandes.

The story, authored by an Associated Press reporter, cited an AP review of “100 pages of Food and Drug Administration reports, [which show that] even modern drug plants here [in Puerto Rico] under the watch of U.S. regulators have failed to keep laboratories sterile and have exported tainted pills.” The reports stemmed from FDA inspections of 13 pharmaceutical plants between 2003 and 2007.

The AP story quotes the FDA as saying “the problems in Puerto Rico are proportionate with the large number of pharmaceutical plants here and generally no worse than those on the U.S. mainland.” However, it attempts to discredit the FDA statement by sandwiching it between an alarmist quotation from a Washington watchdog group and a charge from unnamed “consumer advocates” that the FDA “does not sufficiently monitor the industry across Puerto Rico and the mainland.”

The AP did not respond to requests for comment.

The FDA, for its part, disagrees with the theme of the AP story and reiterates the comment it made to the reporter. “The inspection results from firms in Puerto Rico [between 2003 and 2007] were similar to the types found in other areas of the U.S.,” an FDA spokesman says.

He adds that “the FDA maintains a rigorous inspection process to ensure that firms manufacturing pharmaceuticals are doing so in accordance with the appropriate regulations to make safe and effective drugs.”

The premise of the story, “Tainted Pills Hit U.S. Mainland,” which appeared on February 5 in newspapers produced by several AP subscribers, is akin to ascribing a U.S. state or region (e.g., California, Research Triangle Park, or Eastern Massachusetts) a regulatory authority which trumps that of the FDA, the European Medicines Agency (EMEA), and Japan’s Ministry of Health, Labor, and Welfare Pharmaceutical and Food Safety Bureau.

The story described three contamination incidents over the five-year period: paint flecks on Diltiazem drug capsules, a blood pressure medication made by Biovail Corp.; metal particle contamination in Teva’s diabetes treatment Metformin; and machinery pins inside bottles of Effexor, manufactured at a Wyeth plant in Guayama.

Wyeth issued a statement immediately after the AP story appeared, citing an announcement it had made nine months earlier, in May 2007, that it “had resolved FDA concerns” outlined in a warning letter.

“Also in May 2007,” the current Wyeth statement continues, “the FDA informed Wyeth that its re-inspection of the Guayama manufacturing facility had resulted in a positive re-classification of the site.” Issues found by the FDA had either been corrected or did not merit further action. The statement also mentioned that the Guayama manufacturing facility had passed “three other major regulatory inspections conducted by agencies representing Europe, Brazil, and the Gulf countries.”