Drug imports debate rumbles on
with opposition this week as representatives from the
pharmaceutical industry resisted the move saying there are
'better, safer alternatives' to imported drugs.
The legislation, the Pharmaceutical Market Access and Drug Safety Act, was introduced last year by Senators Byron Dorgan and Olympia Snowe and would allow pharmacists and licensed wholesalers to import federally approved prescription drugs from Canada and other Western industrialized countries for resale in the US. At the moment, only pharmaceutical companies can import prescription drugs for resale. At the Senate Commerce, Science and Transportation subcommittee hearing yesterday, Billy Tauzin of the Pharmaceutical Research and Manufacturers of America (PhRMA) said that importing drugs from outside the US was fraught with dangers and would also not fulfil the cost savings anticipated by some parties. "Importation of medicines in to the US that have been outside the jurisdiction of FDA [Food and Drug Administration] is inherently unsafe," said Tauzin in his testimony before the subcommittee. "There is no assurance that an imported drug meets FDA's stringent requirements for quality, purity, safety, effectiveness or proper labelling. As FDA has documented, many of these imported drugs are unapproved, contaminated, counterfeit, or have been stored, handled or shipped under substandard conditions." Counterfeiting is a major concern for those opposing pharmaceutical imports from outside the US. Even if importation is limited to products from Canada alone, Tauzin claimed that this still leaves the door wide open as, in practice, a drug could be imported from anywhere in the world as long as it entered the US through Canada. Paperwork and chain of custody documents cannot be relied upon to authenticate an imported medicine as they are simply to easy to forge, said Tauzin. "At a time when we are struggling to combat counterfeit drugs and tighten security at our borders, we should be searching for ways to close existing loopholes in the drug distribution chain, not creating new ones by opening up borders to foreign imports," he said. Dr Randall Lutter, acting deputy commissioner for policy at FDA, highlighted other issues of concern regarding the current state of imported prescription drugs in the US. He brought up the fact that many foreign medications, although marketed under the same or similar-sounding names as US brands, actually contain different active ingredients. For example, 'Flomax' in the US is a brand name for a tamsulosin-based treatment for enlarged prostrate, whereas in Italy 'Flomax' is an anti-inflammatory drug with the active ingredient morniflumate. An investigation carried out by FDA last year uncovered 105 drug brand names that were so similar to drugs marketed in foreign countries that patients could easily receive drugs with the wrong active ingredient. For example, 'Ambyen' in the US is an amiodarone drug used to treat life-threatening abnormal heart-rhythms, whereas 'Ambien' in the UK is the brand name of a sleeping pill, said Rutter. There are those, whoever, who wholeheartedly support the introduction of a law allowing the import of drugs from outside the US. Senator Dorgan, who chaired yesterday's hearing, insisted that the legislation was necessary to drive down the monopoly UD drug companies have on controlling drug prices. He noted that that the same drugs manufactured in the same factory routinely sell for twice the price in the US as they do in other countries. According to estimates from the Congressional Budget Office, the proposed legislation could result in savings of €50bn over 10 years, claims Dorgan. As for concerns over counterfeiting and safety of imported drugs, Dorgan dismisses them fervently: "Our bill makes purchasing medicines safer by establishing safeguards that don't exist today," he said. "Such arguments make clear that opponents hadn't even read the legislation, much less thought very much about it." The proposed legislation was also supported by William Schultz of legal firm Zuckerman Spaeder. In his view the legislation addresses the "substantial and serious problem" of patients illegally obtaining potentially dangerous drugs from foreign sources by providing a safe means for US citizens to obtain lower-priced prescription drugs. "I firmly believe that if Congress creates a legal mechanism for providing lower cost drugs, consumers will no longer resort to buying substandard or possibly dangerous drugs off of illegal Internet websites or mail order companies," Schultz said at the hearing. "This legislation creates options: it cerates pathways to ensure that patients have access to safe and effective, lower-priced medicines." With both sides of the argument receiving strong support there is much discussion still to be had. However, Senator Dorgan believes there is enough backing for the legislation for it to pass through the next stages of approval and make it all the way through to the White House and hopefully approved by the President later this year.
