· After more than a decade or working on behalf of providing Americans with access to safe, affordable brand-name medicines from licensed, registered pharmacies outside the U.S., in countries (usually referred to as Tier One countries) whose standards of safety and efficacy meet or exceed those of the United States, I feel compelled to present what I hope will clearly identify why the argument of Pharma and its trade association and many front groups that Americans turning to personal importation of vital medicines to protect their health is flawed.
- · There are virtually no prescription medicines sold in this country that are manufactured in the U.S.
- · It is a matter of record that prescription medicines personally imported from licensed, registered sources outside the U.S. are subject to the oversight of not one but many regulatory agencies and professional industry groups.
- · Significantly, the medicines from licensed registered pharmacies outside the U.S. have a ‘tacit’ endorsement since all are manufactured at U.S. Food and Drug Administration-approved facilities and are subject to FDA Oversight.
- · Additionally, the FDA has announced a new operating philosophy in which it will allow reciprocity of importation of ingredients for prescription medicine manufacture. For many years, supporters of personal importation have urged a series of reciprocal agreements with Tier One Countries, similar to that now adopted by the FDA for ingredients. It is only logical that such a concept of reciprocity be extended to personal importation of prescription medicines.
- · Brand-name medicines are identical to those offered in the U.S. although they may have additional or different labels applied because of the regulations of the countries in which they are manufactured or to meet requirements of pharmacy regulations within that country. This does not alter the safety, efficacy or authenticity of the medicines but is an indication of the extraordinary levels of oversight.
- · The FDA has stepped up its approval of generic medicines, and generics offered for personal importation should be only those already approved by the FDA and offered for sale by US pharmacies.
- · Additionally, there are additional levels of oversight offered by the countries in which the manufacturing of medicines must meet the standards of that country.
- · Safe medicines have been provided for more than 12 years to millions of Americans from licensed, reputable pharmacies in countries whose standards of oversight and safety meet or exceed those of the U.S., and this proven safety record provides yet another verification of the safety and efficacy of personal importation.
- · This includes Internet mail-order pharmacies and pharmacy fulfillment services located in Canada, which are the prime sources of personal importation of prescription medicines in the U.S. Health Canada is recognized as one of the stellar regulatory agencies in the world because of its professionalism and high standards and it has repeatedly noted that these services are in no way violating Canadian law.
- · Additionally, legitimate Canadian pharmacies must be licensed and registered by their provincial regulatory bodies, creating yet more impartial regulatory professional oversight to help ensure the safety and efficacy of the medicines and their handling and dispensing.
- · To provide additional oversight and assurance of safety and meeting professional standards, legitimate Canadian mail-order pharmacies have established the Canadian International Pharmacy Association (CIPA) to certify that a member pharmacy meets its high standards of safety and quality.
- · As an example of the commitment to safety and efficacy, Canadian Internet and mail-order pharmacies, and recognized pharmacy benefit services have also established their own internal oversight services—a Gold Standard so to speak—to be applied to pharmacies outside of Canada to ensure that standards meet or exceed those outlined in this statement and meet their own high standards of the individual entity’s procedures and emphasis upon safety and efficacy.
I submit that these extensive efforts by regulatory agencies, industry members, advocacy groups and policy-makers creates a climate where as one neutral observer has noted that such steps eliminate virtually any chance of a ‘bogus’ operation not being easily identified.