It Takes The FDA How Long To Approve Generics?
5 CommentsBy Ed Silverman // June 13th, 2008 // 5:20 pm
If you answered ‘too long,’ you win a free subscription to Pharmalot. The Office of the Inspector General of the Health and Human Services Department has just issued a report on the FDA’s Office of Generic Drugs and the results are, well, not too stellar.
One key reason - the Abbreviated New Drug Application submissions have increased at more than double the rate of review resources in the last 5 years, the OIG notes. We should point out that all drugmakers must submit ANDAs to the OGD, which has three divisions conducting reviews - chemistry, bioequivalence and labeling. However, most disapprovals are handled by the chem squad.
Now, to the findings - the FDA “exceeded the 180-day review requirement for nearly half of original ANDAs under review in 2006 because Chemistry reviews exceeded 180 days. In 2006, Chemistry did not review 46 percent of original ANDAs within 180 days as required by Federal law.
“For ANDAs taking more than 180 days for review, the median review time was 217 days. Because almost all of these original ANDAs contained chemistry deficiencies, Chemistry’s delay in reviewing these ANDAs resulted in FDA’s delay in disapproving them, regardless of the timeliness of the other divisions’ reviews.”
Microbiology, Bioequivalence, and Labeling reviews of original ANDAs generally exceeded 180 days in 2006. In 2006, the percentages of ANDAs with review times exceeding 180 days were 76 percent in Microbiology, 58 percent in Bioequivalence, and 56 percent in Labeling. For ANDAs taking more than 180 days to review, median review times were 361 days in Microbiology, 287 days in Bioequivalence, and 277 days in Labeling.
Nearly 70 percent of sampled division reviews exceeding 180 days did not begin before the 180-day review periods expired. In a sample of 105 ANDAs with review times exceeding 180 days, reviews for 69 percent did not begin within 180 days. Thus, the 180-day periods passed before division reviews began in most of the sample.
The FDA’s prioritization practices affect Abbreviated New Drug Application review times. FDA prioritization practices contribute to longer review times for ANDAs that are close to approval.
Hat tip to the WSJ Health blog
Nathan
Big deal — the FDA is taking forever to review NDA’s too. It wouldn’t be exactly fair if they were late reviewing NDA’s but then were on-time reviewing ANDA’s. They need to be consistant with both in order to give a “fair” lifetime for brand-name drugs.
Dan
It’s somewhat Pavlovian. Let’s virtually eliminate the requirements of approval mandated to the branded companies, so we can increase the volume of generics. Then the closure time seems to be longer than the development process.
Remember the FDA’s mission statement:
“To promote and protect public health”
Enron had a mission statement, too.
Atlex
Nathan,
I think that the vast majority of these delays apply to generics that are the 5th, 6th, 10th, 12th to market, not the first 2 or 3.
Atlex
CMC guy
While poor performance indeed a limited resources verses burden seems to be largely responsible as “ANDA submissions have increased at more than double the rate of review resources in the last 5 years”. There were 989 submissions in 2006 so is a huge amount of information to deal with. I don’t know how many Chemistry Reviewers FDA has in total much less ones dedicated to OGD (to those who do not know Chemistry includes Chemistry, Manufacturing and Controls, CMC, and is typically bulk of an ANDA unlike NDAs which are largely Clinical. CMC Sections are highly technical and diverse in content). Looking at time factor alone may be a bad metric as impression is iterative since appears other areas don’t really engage until Chemistry passes.
The fact that only 4% get approve/approvable (96% reject) is very curious. Although some generics submissions come from inexperienced manufacturers there are many that should know how to it right.
Dan
My opnion, but there seems to be a correlation between the PDUFA and priority reviews doubling in only a period of a few years. Eight years ago, if a pharma company paid the FDA a solid million dollars aside from the PDUFA, they have bought a priority review. A little known fact.