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Non-governmental certification agencies are better than nothing, but are they good enough?
While two US organizations—the National Assn. of Boards of Pharmacy (NABP) and a private company called LegitScript (Portland, OR)—provide certification of the legitimacy of online US pharmacies, there are only nongovernmental organizations looking at non-US online pharmacies (or, at least, the online pharmacies that want to attract US consumers). The two best known of these are PharmacyChecker.com (White Plains, NY) and the Canadian International Pharmacy Assn. (CIPA; Winnipeg, MB). Two researchers at the American Enterprise Institute (Washington, DC) have investigated how well the online pharmacies vetted by these agencies do in providing safe, non-counterfeit product to online purchasers, and the answer that comes back is: pretty good, at least for popular branded drugs.
One of the researchers, Roger Bate, an adjunct scholar at AEI, has been studying counterfeit drug distribution globally for years. To test the reliability of the online pharmacies, the researchers performed anonymous purchases of five branded drugs, then tested the purity of the products with a portable spectrophotometer (the TrueScan device of Thermo Scientific). Online pharmacies were subdivided into three tiers: US online pharmacies certified by the NABP VIPPS program or LegitScript (tier 1); US and non-US pharmacies certified by PharmacyChecker or CIPA; and uncertified pharmacies (tier 3). Tier 1 and 2 pharmacies’ products were legitimate; some Tier 3 products were not. The drugs tested from Tier 2 were, on average, 49% cheaper than Tier 1 pharmacies; for Tier 3, the discount was 54%.
A parallel study of consumer attitudes was also performed; this study showed among a select group of American consumers (as represented by RxRights, an online association of consumer-rights groups), 62% made purchases from foreign pharmacies, and are primarily motivated by price; and that 41% of them pay attention to credentialing agencies.
The authors’ conclusion:
Both samples [i.e., of pharmacies and of the consumers polled] convey a consistent message that certification agencies deliver useful information for foreign websites and online consumers. Further, while these findings confirm the Food and Drug Administration warning against rogue websites, they do suggest that a blanket ban against all foreign websites may deny consumers substantial savings from certified tier-2 websites.
“If nothing else, these certification processes signify that the online pharmacies know that they’re being watched,” Bates comments. “The stance of FDA has always been clear, that non-US pharmacies are essentially unregulated and risky. But from a humanitarian perspective, public health agencies and states concerned with health costs should be addressing the needs of patients who can’t afford to buy the drugs they need at US prices.”
The subject is not one of purely academic interest; last June, the Maine legislature voted in a law to allow imports of drugs from the UK, Canada, Australia and New Zealand; the law has been contested in litgation brought by PhRMA and local pharmacy groups. Other states are looking to re-open the activity, which was rising prior to the implementation of Medicare Part D in 2006, but then tailed off as that program took hold. But with the Affordable Care Act under continual attack by the US House of Representatives (and with the pharma industry’s support of that law contingent on keeping drug imports out), the subject could again return to active debate.
The AEI study appears in the J. of Economic Policy and Analysis, and is available for purchase there.