PHARMA: The progress of reimportation, by The Industry Veteran

It looks like the Senate is going to pass the re-importation bill and then try to force the House to come on board. If, as I’ve been saying for a while, the Republicans are going to cave on this and do something before the election to preserve what little credibility the Medicare PDIMA bill has left with seniors, it’s worth thinking through what might happen next. Luckily for me and you, The Industry Veteran has already done so, so strap yourself in for a typically meek analysis of what’s going on. (Note that this piece is a couple of weeks old, as it was lost in my inbox mess on my vacation, but it holds truer today than when it was written!)

    Republicans in Congress have finally acceded to the public’s demand for ready access to pharmaceuticals reimported from Canada and other countries. HHS Secretary Thompson said he will advise George Bush not to oppose the effort. This means the President must focus his pharisaical, malevolent gaze at Hank McKinnell, Fred Hassan and the other plutocrats of Big Pharma and tell them that despite their $100 million contributions to his cloak-fascism-with-Christ administration, he has to look out for himself. In the short run this will provoke wounded howls and threats about the loss of high paying jobs, but Big Pharma is apt to remain one of the world’s most profitable industries. Organized medicine, for example, resisted Medicare from the 1940s through the mid-60s with shrieks about socialized medicine. As a result of LBJ finally getting the legislation through, physicians annual incomes rose from $50,000, respectable at the time, to the point where today, oncologists earn a median income of $450,000 and leave respectability behind them in the dust.

    The Republicans intent to actually permit some form of reimportation appears from the fact that their proposal was drafted by the Chairman of the Senate s Health, Education and Labor Committee, Judd Gregg, at the behest of the Senate Majority Leader, HCA’s Bill Frist. The legislation would permit transhipment from other countries, through Canada, providing: (1) the FDA can approve facilities through which the drugs pass and; (2) the tracking (or "pedigree") of shipments can be maintained.

    Some features in Gregg’s bill include:

    — Individuals can receive their prescription medications (a maximum 90-day supply at a time) from licensed pharmacies in Canada or up to 15 EU countries approved by the FDA. All businesses involved in reimportation must register with the FDA, submit to FDA inspections and must permit the agency to detain or suspend shipments in theinterests of public safety;

    –Internet pharmacies must comply with all current, federal, state and local regulations governing pharmacy practice;

    –Importers must identify entry ports, provide advance notice of incoming shipments, and grant the FDA authority to mark suspected shipments in order to prevent their entry into another port;

    The details in which Republican devils (a tautology if there ever was one) may lurk involve the requirement that pharmacies, wholesalers and others in the distribution channel must maintain a pedigree of a shipment’s s immediately prior source and subsequent recipient. Shipments from Canada would need to identify all previous entities in the supply chain. The import system would establish a user fee for all participating businesses, the money presumably enabling the FDA to discharge these oversight responsibilities.In principle the facility approval and tracking provisions appear desirable as measures for controlling the drug counterfeiting that occurs even today in the U.S.’ loosely monitored landscape of mom-and-pop wholesalers. It remains an open question, however, whether a Bush-influenced FDA that orders its top reviewer not to comment about a drugs hazards at an advisory committee hearing can capriciously seize upon ambiguous situations to logjam the entire process.

UPDATE: Gregg was reported to be introducing the bill by the Washington Post this morning

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