It’s time for FDA to become more transparent on prescription drug recalls

I read the following disturbing Q&A in Joe and Teresa Graedon’s People’s Pharmacy column this morning:

Q: I once worked for a pharmaceutical company that ordered a raw ingredient, diphen-hydramine, from China. I was a quality-assurance inspector and had to inspect incoming material.

That ingredient was trashy, with what looked like a lot of floor sweepings and black blobs of something I could not identify. I placed all of that shipment on reject. I came in to work the next day and was told by the boss that he had authorized the release of that ingredient to be used in production!

When I left work later that day, I called the Food and Drug Administration and reported the whole thing. I called in the next day and quit my job.

A: We forwarded your shocking story to the FDA but have not received a response. Diphenhydramine is an antihistamine found in dozens of allergy medicines as well as sleep aids and nighttime pain pills.

Past experience with adulterated heparin and milk products, as well as pet food, suggests that Chinese ingredients require monitoring. A recent report from the Institute for Safe Medication Practices concludes, “It is increasingly clear that the nation is experiencing serious problems in ensuring that generic drugs are manufactured with adequate quality control.”

By now, we’ve all heard horrors stories about unsafe drugs, food, toys and other products imported from China. But I’m still amazed that the American public hasn’t been calling for the heads of government officials over this problem; it’s a basic responsibility of our government to keep its citizens safe.

In a report issued earlier this month, the Institute for Safe Medication Practices (ISMP) argues that one reason the public has not been more outraged is that the FDA has been less than forthcoming in sharing information. While the public knows that there have been recalls, the ISMP says, it doesn’t know just how serious the problem is.

As the ISMP summarizes the issue:

Concerns continue regarding serious problems our nation seems to be facing to ensure generic drugs are manufactured with adequate quality control.

In the first quarter of 2008, there were urgent recalls of most of the nation’s supply of one form of generic heparin and millions of fentanyl patches from several generic drug manufacturers. In the second quarter, about 50% of the nation’s supply of generic digoxin was recalled because over-strength tablets may have been manufactured and distributed. An additional generic digoxin recall was announced in March 2009.

In the third and fourth quarters of 2008, urgent recalls were announced for generic versions of morphine sulfate, propafenone, and isosorbide. All involved over- or under-strength tablets that could have significant health consequences. In addition, two NJ plants of the Actavis Group were closed and all products manufactured there were recalled due to manufacturing concerns. In December 2008, KV Pharmaceuticals’ plants were closed to resolve quality control problems.

The concern regarding the manufacture of generic drugs has received little public and official notice in part because FDA does not require disclosure of the size and impact of a product recall. To cite one example, neither Caraco Pharmaceutical Laboratories nor FDA would reveal how many digoxin tablets were involved in its March 31, 2009, recall notice.

Based on these findings, it seems apparent that FDA’s current system for inspecting plants, dealing with violations, and managing product recall notices requires systematic independent review.

While we’re not sure (yet) that an independent review of FDA practices is necessary — we may see significant change with the new leadership President Obama has put in place — we agree strongly that the FDA should share more information about the risks and dangers it is encountering in our drug supply.

That’s only fair to the public. It’s a step Obama’s FDA should take immediately.