Today, the FDA debuted a new page on their website called Upcoming Product-Specific Guidances for Complex Generic Drug Product Development. Its stated purpose is to provide “information related to upcoming new and revised product-specific guidances (PSGs) to support the development and approval of safe and effective complex generic drug products.” This comes after several public meetings, seminars on complex generic products, and lots of discussion regarding complex products. The webpage can be accessed here. The interest in complex generic products has increased significantly over the last decade and is now a burgeoning population of current ANDA filings which, after approval, can have significant impact on lowering consumer prices for these products.
Complex products come in all types and may include those with a complex API, drug/device combination, products without a clearly defined bioequivalence path, a complex formula, route of delivery, or dosage form. The FDA has been working to gain ground providing recommendations for products coming off patent and has also been addressing older products that had been delayed because there were no appropriate methods to demonstrate either equivalence of some aspect of the product or bioequivalence.
The science has advanced and now the OGD (in cooperation with its counterparts in new drugs) is beginning to get ahead of the curve. The overall goal is to reduce the number of review cycles and, thus, the time to approval for these products. Many complex products had previously languished in the review and approval process for seven to ten years or more while the Agency and industry were figuring out the appropriate path to approval. Now, as complex generics are in the spotlight, hopefully that approval time can be considerably decreased through the Agency’s initiatives.
The new webpage identifies fifty-seven planned PSGs for complex products and eighty-six PSGs up for revision (see URL provided above). Truth be told, whenever I hear the words “revised PSG,” I cringe. But the FDA has gone one step further to alleviate some of the fear that those words strike in hearts of industry veterans like myself by outlining three types of revisions:
- Major Revisions – where new or additional studies may need to be undertaken.
- Minor Revisions – “when a PSG is to be revised to remove certain studies, to provide alternative (less burdensome) approaches to the currently recommended studies, to add information on newly approved strengths of the RLD, or to make other recommendations that would not generally result in additional recommended bioequivalence studies or evidence by an ANDA applicant.”
- Editorial Revisions – where errors are corrected, additional citations are added, or where “streamlining the format of existing recommendations” is undertaken.
One of the very nice things that the OGD has done, and that we have been suggesting for years, is to outline the nature of the changes that are made when a guidance document is listed as revised. They did that for the eighty-seven PSGs for complex products with planned revision and, of those, there were only three MAJOR revision categories outlined, which added new study requirements for three products:
- Levonorgestrel intrauterine device – added an in vivo bioequivalence study for generic duplicates of RLD NDA 203159
- Oxycodone extended-release capsules – added an in vitro feeding tube study for generic duplicates of RLD NDA 20809
- Testosterone implantation pellet – added additional partial AUC recommendations for generic duplicates of NDA 080911
Wouldn’t be nice if this type of information were made available for all PSG revisions? Well, one step at a time! Anyway, thanks, FDA, for moving forward on the initiatives for complex generic products. Its end result will be a great service to patients!