Over the past year, imported drugs and drug ingredients have become a big issue. Beginning with the big heparin recall last January, eventually traced to suppliers in China, major holes in the import safety net have been exposed. FDA has taken some steps to darn those holes--opening inspection offices in China, for instance--but the fact remains that the U.S. drug supply relies on thousands of foreign plants churning out active ingredients and finished meds.
Till now, the debate has focused primarily on the safety of those foreign-made products. With a new president coming into office and a new Congress seated, the aim is turning to security. Is the United States too reliant on drugs from abroad?
There's no question that much ingredient manufacturing and drugmaking is moving to cheaper climes in China and India. That includes crucial meds like antibiotics and diabetes remedies. So some lawmakers are calling for legislation that would require certain drugs to be made or stockpiled domestically, the New York Times reports. "The lack of regulation around outsourcing is a blind spot that leaves room for supply disruptions, counterfeit medicines, even bioterrorism, Sen. Sherrod Brown told the newspaper.
Take preparation for a potential flu pandemic. The government has invested billions in the vaccine infrastructure, hoping to build up the expertise and capacity to quickly turn out millions of doses of a pandemic vaccine. The government has also invested in stockpiling the antivirals Tamiflu (Roche) and Relenza (GlaxoSmithKline). But recent studies show that most of those who died during the 1918 flu pandemic actually died of bacterial infections rather than the flu itself. And penicillin, which is a key ingredient for two classes of antibiotics, is exclusively made overseas.
Security concerns are well and good, but with pharma suffering its own troubles, moving manufacturing back to higher-cost locations just doesn't seem feasible without government spending. Dr. Yusuf K. Hamied, chairman of the ingredient supplier and drugmaker Cipla, told the Times just how dependent pharma now is on overseas plants: "If tomorrow China stopped supplying pharmaceutical ingredients, the worldwide pharmaceutical industry would collapse." Can you say stimulus package?
- read the NYT story