Might Drug Companies Abroad Skip the US?
A recent Wall Street Journal article suggests that some European companies may consider skipping the US market when it comes to rolling out their new drug products on a global scale. The reason: regulatory roadblocks.
Although FDA and its European counterpart, EMEA, have had similar approval processing times in years past, FDA tends to have more variability in its approval times, according to the article. Plus, FDA may be making more conservative decisions these days due to recent problems with contamination of imported drugs, not to mention increased Congressional scrutiny.
As a result, international companies don’t want to waste their time jumping through additional hoops here in the US. They can simply go elsewhere. Take Novartis, for example, who told the WSJ that if FDA’s “requests for additional clinical testing on patients with kidney problems” for the diabetes drug Galvus prove “too onerous,” the company may withdraw its US application.
GlaxoSmithKline and Sanofi-Aventis also have drugs that have received EU, but not US, approval.
If companies with good, safe drugs abroad truly start skipping out on the US market, might we here at home essentially be “skipping out” on our own patients in need of quality medication?
The question about “companies with good, safe drugs abroad” and the US market pretty well answers itself: Of course they’ll take the time to gain FDA approval. Not to criticize Novartis or any other eithical manufacturer of drugs for, e.g., treatment of diabetes, but products like Galvus aren’t going to have an easy time at FDA.
In view of recent allegations in JAMA [2008;299(15):1800-1812 and 1833-1835], some regulators, politicians, and patients may wonder if international drug companies will avoid US registration because of problems with their dossiers — and citizens in the US may conclude that, on balance, this may be a good thing for US consumers.