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PhRMA unhappy with Maine’s new drug import law

Posted in Legal Issues

As reported by FDA News, the state of Maine has passed a law that green lights the use of imported prescription drugs through internet pharmacies.  The new law goes against past federal restrictions on drug imports that were established in order to inhibit the sale and use of medication that did not meet the federal standard.

Online pharmacies located in countries such as Australia and Canada are now able to sell their products in the United States.  These drugs are not properly screened by the FDA for their safety and often sold at a lower cost.  Some feel there is a problem with an individual state’s law that allows for the sale of prescription drugs through online pharmacies located in different countries because federal law supersedes state law.  So in this case, importing foreign pharmaceutical products could be considered illegal.  The U.S. Attorney General’s office and FDA declined to comment on the recent activity, and the executive vice president of pharmaceutical trade group PhRMA is worried that the pharmaceutical industry’s reputation is on the line.

The FDA had previously warned back in 2003 that the distribution of these online drugs from pharmacies that were based in foreign countries could expose American citizens to risky products – these drugs are being shipped from an unregulated source where the shipping methods are even under scrutiny.  Drug companies have been trying to develop a nationwide practice of accurate tracking and tracing of medications, and Maine’s new law would greatly inhibit this effort as medications would be coming from a completely different (international) system that operates independently.

In September, a lawsuit was filed seeking to stop the new law by PhRMA, the Maine Pharmacy Association, and other independent groups.  Some argue that a provision in the 1938 FD and C Act does not allow foreign drugs that are not properly screened and approved by the FDA to be sold in the United States.