Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Federal Judge Strikes Down Maine Drug Re-Importation Law: Is It a Victory for Patients or for Pharma?

Federal Judge Strikes Down Maine Drug Re-Importation Law: Is It a Victory for Patients or for Pharma? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A federal judge has struck down a 2013 law that allowed Maine residents to buy prescription drugs by mail from other countries, often at a significant discount.


U.S. District Court Judge Nancy Torresen ruled Monday that Maine’s law circumvented federal law, which permits state-to-state drug sales but prohibits international imports. Her decision renders the law invalid, although the state can appeal.


The primary plaintiffs in the case – the Maine Pharmacy Association and the Retail Association of Maine – praised the decision, but former state Sen. Troy Jackson, who sponsored the bill that became law, was disappointed.


“The pharmaceutical industry wins these things 10 out of 10 times, so I’m not surprised,” said Jackson, a Democrat from Allagash.


Timothy Feeley, spokesman for the Maine Attorney General’s Office, said no decision has been made on an appeal. He did say that, in light of the decision, “Congress and the FDA should re-examine their policy toward importation of prescription drugs.”


Maine’s 2013 law was the first of its kind in the nation. It was passed to address a 2012 decision by then-Attorney General William Schneider that halted the popular CanaRx program, which allowed Mainers to buy cheaper prescription drugs across the northern border.

The law identified four countries from which residents could buy prescriptions over the Internet – Canada, Australia, New Zealand and the United Kingdom. Those countries were chosen because they have similar safety regulations and oversight, but can charge less for drugs because of deals with pharmaceutical manufacturers.

Pharma Guy's insight:


The Pharmaceutical Research and Manufacturers of America hailed the decision:


“This is a significant victory for patients,” John Murphy, the trade group’s associate general counsel, said in a written statement. “It confirms the important role the (Food and Drug Administration) plays in regulating the drug supply chain and protecting consumers from counterfeit and adulterated medicines that may be inserted into an unregulated supply chain like the one Maine sought to facilitate.”


Meanwhile, IMHO, PhRMA should be concerned about its own "pink slime" issue: Did you know that up to 80 percent of the active ingredients in drugs used in the United States are made overseas? Hopefully, those ingredients meet high standards. Yet up to 149 Americans died in 2007 and 2008 after taking heparin, a blood thinner, contaminated during the manufacturing process in China. For more on that, read Will Pharma Experience It's Own "Pink Slime" Social Media Crisis?

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FDA Bans Chinese Heparin Because it was Made from Cow Intestines. Doesn't address real issue: Contaminants

FDA Bans Chinese Heparin Because it was Made from Cow Intestines. Doesn't address real issue: Contaminants | Pharmaguy's Insights Into Drug Industry News | Scoop.it
The FDA has taken steps against a Chinese heparin maker it says is using potentially tainted raw supplies and which refused to let inspectors get a good look at its plants or records so that it could find out for sure.


the FDA said test results confirmed the presence of ruminant DNA in one of two samples of porcine crude heparin produced by Shunxin and obtained from one of its Chinese customers. FDA rules require heparin be manufactured only from pig intestines because when "ruminant" animals like cattle are used, there is a chance the raw material could be contaminated with bovine spongiform encephalopathy (BSE).


FDA inspectors didn't get a chance to find out the extent of potential problems because the company "repeatedly" refused to let inspectors into the production area or to review records. The FDA said products from Shunxin will be barred from the U.S. until the FDA can inspect its plant and its records and determine if its manufacturing meets FDA standards.

Pharma Guy's insight:

Cow, pig, whatever! The real problem is the adulteration of the heparin with lethal contaminants used to increase profits, just like street drug dealers do. How is FDA protecting us from that these days considering Chinese companies may refuse to allow FDA inspections?


From a 2010 Pharma Marketing Blog post (see "Unsafe Drugs: Is It Counterfeiters or the Supply Chain That's the Problem?"):

 

"Up to 149 Americans died in 2007 and 2008 after taking heparin, a blood thinner, contaminated during the manufacturing process in China," according to the 2010 "Drug Safety and Accountability" bill recently introduced in the Senate by US Senator Michael Bennet, a Colorado Democrat (find that bill here).

It wasn't the active ingredient in Heparin that caused the problem, it was a contaminant that was deliberately added to heparin batches that were processed in China from pig's intestines by the American pharmaceutical firm Scientific Protein Laboratories. The contaminant mimics the in-vitro properties of heparin, but is much cheaper than heparin, which is obtained from pig intestine. It seems that there was a shortage of pigs in China at the time, perhaps due to efforts to curtail swine flu.

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