Bill could cripple FDA and harm patients; PhRMA

By Nick Taylor

- Last updated on GMT

The backlash against the re-importation bill has begun, with PhRMA warning that the legislation could cripple the FDA’s ability to protect patients and open the door to counterfeits.

Senator Dorgan introduced the bill, which he thinks could save the US $50bn (€39bn) over the next decade, but the industry believes that allowing wholesalers and pharmacies to buy drugs from foreign countries will see a rise in counterfeits.

Dorgan’s bill only allows importation from certain countries, such as Britain and Canada, and requires that the manufacturing facilities must be inspected by the US Food and Drug Administration (FDA) but some maintain these measures are insufficient.

The Partnership for Safe Medicines, which is lead by Pharmaceutical Research Manufacturers of America’s (PhRMA) director, also entered the debate saying the bill would “encourage Americans to gamble with their health​”.

In a press statement it went on to claim that the US had one of the safest drug supplies in the world because the supply chain is "closed​". This was contrasted with the system in other established markets, which the group believes would put US consumers at risk.

It said: “Advocates for drug importation believe that drugs purchased from countries such as Canada and Britain are subject to strict health regulations and oversight and are therefore safe. This is a dangerous misconception because Canadian regulators do not carefully scrutinise drugs bound for the United States​.

There is also a clear link between drug importation laws and counterfeit drugs. Policymakers need only to look at Britain to see how counterfeit drugs infiltrated its national drug supply in 2007 using parallel trade agreements and lead to four emergency recalls​.”

The Partnership for Safe Medicines’ executive director is Scott LaGanga, who is also the director of PhRMA. In addition PhRMA has a seat on the four person board, which also includes the executive director of the​Pharmaceutical Security Institute and two academics.

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