Kill the lawyers! I mean kill ALL the lawyers! What my drugs are tainted? I meant kill all the tort-deformers!
Could the next recall scandal be prescription drugs from China?
I pose that question and ask you, "Can we afford the same problems with drugs as we have with toys?" Take a look at this quote from
We've already highlighted the New York Times story this week that exposed the frightening reality of the Chinese pharmaceutical market. What does it mean for the American consumer? Over the last six years, manufacturing of active pharmaceutical ingredients (AIPs) has been increasingly moving to China and India, to the point that now, approximately 80 percent of the active pharmaceutical ingredients that go into the finished medicines Americans will consume are manufactured abroad, mostly in those two countries. Neither China nor India has the same regulatory standards as the U.S. and the European Union. Moreover, U.S. regulators are not able to carry out the same degree of oversight at foreign production facilities as they do at home. By law, FDA has to inspect domestic drug manufacturers at least every 2 years. However, of the 700 FDA-registered firms in China, the agency was able to carry out inspections at only 17 last year. Even more alarmingly, firms that are not registered with the FDA, such as Chinese chemical companies that are making pharmaceutical ingredients illegally, never get inspected. According to the Times, China has an estimated 80,000 chemical companies, but our FDA does not know how many sell ingredients used in drugs consumed by Americans. The pharmaceutical industry stresses that there is a duality to the regulatory system: government oversight on the one side and the company's own quality control on the other. Yes, the pharmaceutical companies try to ensure that their supply chains are not compromised, but how successful can they be when even the local authorities in countries like China have no idea who is producing what components for the medicines that end up on the world market?
Neither China nor India has the same regulatory standards as the U.S. and the European Union. Moreover, U.S. regulators are not able to carry out the same degree of oversight at foreign production facilities as they do at home. By law, FDA has to inspect domestic drug manufacturers at least every 2 years. However, of the 700 FDA-registered firms in China, the agency was able to carry out inspections at only 17 last year.
Even more alarmingly, firms that are not registered with the FDA, such as Chinese chemical companies that are making pharmaceutical ingredients illegally, never get inspected. According to the Times, China has an estimated 80,000 chemical companies, but our FDA does not know how many sell ingredients used in drugs consumed by Americans.
The pharmaceutical industry stresses that there is a duality to the regulatory system: government oversight on the one side and the company's own quality control on the other. Yes, the pharmaceutical companies try to ensure that their supply chains are not compromised, but how successful can they be when even the local authorities in countries like China have no idea who is producing what components for the medicines that end up on the world market?
Does this even need debate? Don't kill the lawyers kill the tort-deformers!
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