This morning I read Joe Graeden’s (The People’s Pharmacy) article titled “Can You Trust Generic Drug Quality” (here) and, as a former longtime senior official at the FDA who worked in the Office of Generic Drugs and have consulted for the industry for over twenty-five years, I had a kind of knee-jerk reaction and wanted to write back to Joe (we have had at least one conversation in the past) but I stopped and let my knee rest back on the floor.  When I calmed down a bit, I decided I needed to write this blog post.

Now I have to give Joe credit, he will call out the FDA when there is a problem (i.e., 300 mg generic bupropion debacle among others) no doubt, but, in my opinion, he does not give the pharmaceutical industry (especially the generic manufacturers) enough credit and instills a level of angst by broadly indicting generic drug quality.  Since Hatch-Waxman was passed about thirty-six years ago, the FDA has approved over 20,000 generic versions of brand-name products.  We all realize that, even with brand-name products and, as a matter of fact, of the products he mentions in this article, Zantac is a brand-name product approved as an NDA, there can be problems, such as recalls or NDA withdrawals for products that, when in widespread distribution after approval, are shown to have serious side effects that did not show up in the clinical trials supporting approval.

The generic drug program and industry has saved consumers trillions of dollars over the years and has made therapies affordable that were previously out of reach for consumers because of price.  Have there been some bumps in the road along the way?  Sure, but how many millions of automobiles are recalled each year for problems that could cause serious or life-ending accidents?  I am not excusing quality in the drug supply.  Are there bad actors?  Yes, I actually helped guide the FDA back from the days of the generic drug scandal!  Could the FDA be doing a better job?  Well, yes, always, especially with more resources.  But can you expect to catch everything, find every problem, or anticipate something that goes wrong?  Not possible!  Pointing to the “sartan” issue in his article and the NDMA issue, so far not even the manufacturers or the FDA can fully define the origin of the problem.  Some say the NDMA increase noted in the marketed products forms over time due to a thermal reaction during the product’s shelf life, but so far no one knows for sure.

Have there been other problems, like lapses in quality departments, resulting in a number of drug recalls?  The answer is yes, but if you take a look at the number of generic approvals and the number of NDA approvals per year (about 800 versus 60 per year) and then look at the percent of recalls versus the number of applications, the percentages are actually about the same.  Wouldn’t it be nice if the quality processes could eliminate all recalls for quality issues?  Of course, but with the number of things that can go wrong in drug manufacturing from the raw materials used to synthesize the API or issues at the API manufacturer, to the manufacturing floor of the pharmaceutical company, to the storage conditions throughout the supply chain or even at the pharmacy, there are a number challenges that may not always be met or even recognized until the patient receives their prescription.  However, the vast majority of the drug supply is safe and the vast majority of the generic drugs that patients take do exactly what they are supposed to do.  Could there be problems along the way and should there be consequences when those problems are seen?  Obviously, but, remember, the most expensive prescription there is, is one that the patient does not take.  If the patient cannot take a medicine because of cost, then that is shameful, but generic drug products help patients be able to get the medication they need to keep them healthy.  Should consumers have a problem with a product, then they should report the problem, but let’s not introduce fear when the vast majority of generic products are very much as safe and effective as their brand-name counterparts that also sometimes get recalled, have impurity problems, or have lots that fail some specification over time.