Importation Law and Mandatory FDA Inspections

Not too long ago, a bipartisan group of senators incould be even more damaging to the pharmaceutical
the United States introduced legislation that couldindustry. The other section of bill outlines a plan that
spell big problems for the pharmaceutical industry.mandates that drugs may be imported to the United
The "Pharmaceutical Market Access and Drug SafetyStates, only if they are imported from FDA approved
Act" is a piece of legislation being pushed through themanufacturing plants. Now this would sound like a
Senate to immediately reduce drug prices forpretty reasonable stipulation, if the United States
consumers, which will ultimately force the Bio-Pharmaimported its drugs from a lot of FDA approved
Industry to have to drastically reduce the price ofmanufacturing sites. But as of right now, only about 1
drugs here in the United States. According to thein every 13 foreign plants are inspected by the FDA,
Congressional Budget committee, this piece ofand some fear that in lesser developed countries like
legislation could ultimately save the AmericanIndia and China, they would face an even tougher
consumer upwards to 50 billion dollars over the nexttime passing inspection.
decade. However, some in the pharmaceuticalIndia and China are some of the fastest growing
industry are crying foul.drug makers on the globe, but they are also some of
Many pharmaceutical consultancy firms are seeing thisthe least inspected. There is no doubt that their
as a big headache for the pharmaceutical industry.pharmaceutical industries would be hit hardest by this
They see this move by the federal government asmeasure. However, not everyone feels this measure
being very poorly timed, as the pharmaceuticalhas enough teeth to really make any substantial
industry, which was a booming field for so long, haschange in the quality of imported drugs. Many critics
started to face some major setbacks. Theare citing the lack of oversight in many of these
pharmaceutical industry, already suffering from lossesforeign countries, as well as widespread corruption,
coming from cheaper, generic medicines, doesn'tand doubt that these widespread FDA inspections will
know if it can take another 50 billion dollar hit overreally make any impact.
the next ten years. Along with many importantIf you liked this article about a pharmaceutical
patents expiring in the next few years, and sparselyconsultancy firm, tell all your friends about it. They'll
populated drug pipelines, this measure is causingthank you for it. If you have a blog or website, you
plenty of headaches in the pharmaceutical industriescan link to it or even post it to your own site (don't
executive branch.forget to mention as the original source).
Another part of the bill, that is getting less publicity,