At long last, the Food and Drug Administration and our nation’s Congress are beginning to see how important quality control in drug manufacturing facilities is to public health and safety, something we’ve understood at Childers, Schlueter & Smith for quite some time. The FDA is launching a new regimen of quality-control initiatives aimed at overseas drug manufacturing, potentially empowering former and current victims of drug companies with sloppy production techniques.
Because the U.S. imports so many drugs and pharmaceutical ingredients at this point, the FDA now realizes that the demanding standards they place on U.S. production facilities are going to have to be employed elsewhere as well in order to truly protect the American public. About 40 percent of drugs consumed in the U.S. are shipped from abroad, and 80 percent of active ingredient makers are located outside the U.S., according to FDA reports. You can imagine what that means for the scope of the new policies.
FDA officials just launched a pilot project that loosens import restrictions for those drugmakers that the agency respects, freeing up inspectors to focus on less reliable companies. The FDA said its India drug inspection workforce will grow to from 3 positions to 10. There are also plans to create a central U.S. office dedicated to pharmaceutical quality.
Concerns that U.S. regulators were ill-equipped to police globalized drug manufacturing have been simmering for some time. A wake-up call came in 2008 when more than 50 people died after using Baxter Healthcare Corp.’s blood thinner heparin which the FDA found had been contaminated with ingredients made in China.
The flood of new initiatives goes hand in hand with an intense interest from the U.S. Department of Justice in pursuing civil and criminal cases against messy manufacturers. Early last year, one official from the department vowed to take an especially hard look at breaches of good manufacturing practices and bring those companies not up to par to justice. The FDA and Congress have begun to hold drugmakers liable for every step of the supply chain, where multiple companies often play a role in creating a single product. Last year, an important guidance document about contract manufacturing made clear that both drugmakers and their contractors are responsible for ensuring quality.
There is no question that Congress is pushing both the FDA and the Department of Justice to criminally prosecute people in the pharmaceutical industry who do not follow the law. Congress has come to the conclusion that civil fines are no longer effective when up against a massive drug conglomerate.
It’s possible that the additional FDA inspections will lead to more recalls, which can fuel investor suits as well as personal injury suits. Last year, for example, Johnson & Johnson paid $23 million to end a shareholder complaint over an alleged cover-up of production errors linked to a massive recall of medicine.