The FDA and Overseas Drug Approvals – Where is the Most Promising Pipeline?

J0437216For a while now, I’ve been thinking about the growing number of drugs that are being approved overseas and going on the market overseas, but are not getting approved or are getting approvable letters in the U.S.  It is a list that is growing.

Then today, the Wall Street Journal carried an article entitled Overseas Drugs Hit Regulatory Snags and details some of the drugs that are on the market elsewhere, but not in the U.S.  The article mentions several large companies such as GlaxoSmithKline, Novartis and Sanofi-Aventis for Cervarix, Galvus and Rimonabant, respectively.  Not mentioned are also some smaller companies, such as the Canadian firm Labopharm which has not gotten approval for once daily Tramadol even though it is approved in Canada.  The article accounts for the post-Vioxx jitters on drug safety and a lack of FDA funding.

However, as pointed out here many times, there is more at work than a lack of funding or the current risk-averse environment.  In fact, there have been budget increases and PDUFA increases – so money is flowing from both the public and private side, yet product approvals and enforcement continue a downward path.  A more cautious approach might account for a slowdown in approvals and a rise in approvables, but not a lack of funding where money is up and the number of new compounds submitted is down.  And neither a lack of funding or a risk-averse environment explains a lower enforcement rate.

The issues at stake are more comprehensive than money or safety issues and it is going to take a comprehensive strategy to pull the agency and the industry out of the current situation.  Right now, as Congress launches multiple investigations, there is no sign of that happening and it will likely be Congress that re-writes the FDA page.

Does the approval slowdown downgrade the desirability of the American marketplace?  Probably not.  It may be inconvenient for patients, treaters, companies and investors, but the reality remains that the U.S. is by far the largest market for pharmaceutical products and the current situation isn’t likely to change that.   According to the European Federation of Pharmaceutical Industries and Associations, North America represented 47.7% of sales of the world pharmaceutical market, while Europe represented 29.9%.  EFPIA also has compiled other relevant statistics on the European market compared to the U.S. Market in The Pharmaceutical Industry in Figures.  One of the facts is that between 1990 and 2006 investment in new research in the U.S. grew 5 times while in Europe it grew 2.9 times.  If the U.S. regulatory market does not straighten out, that investment may find reason to ebb away.   

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