New Legislation Imposes Document Reviews, Risk-Based Drug Inspections and Increased Drug Listing & Drug Registration Requirements
The Food and Drug Administration Safety and Innovation Act (S. 3187) was signed into law by President Obama on July 9th of this year. The Act brings numerous changes for the drug and medical device industry but all of the attention so far has been on the Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee Act (MDUFA) provisions and user fees. But there are considerable changes in the legislation to how FDA conducts “inspections” that dramatically increases (unnecessarily) the drug establishment registration and drug listing requirements. For instance, under the new authority, FDA is required to target its drug inspection activities using a risk-based model, which will be informed by such risk factors as compliance history of the facility, prior recalls, and inherent risks associated with the manufacturing process and resulting drugs. Further, FDA is permitted to demand submission of receiving, manufacturing, and batch documents and records in advance of or even in lieu of an inspection. Moreover, and the focus of this blog, Sec. 703 of the Act now mandates that drug manufacturers of certain drugs must identify all of their excipient suppliers when they register and list with FDA.
Did you catch that? Drug manufacturers must tell FDA who all their excipient suppliers are. Take a few ibuprofens and keep reading.
What is an excipient? Drug excipients are ingredients in a drug that aren’t the active drug ingredient. For example, the gel coating, the binder, the coloring, the tablet marking that says “500mg, etc…” There are many excipient ingredients in nearly every finished drug on the market; a fact that every drug manufacturer knows all too well. But let’s think about the effect of this for a moment. Each inactive, excipient drug ingredient used to make a drug could come from 3 or 4 different suppliers. Additionally, a single inactive ingredient, for instance, the tablet marking on a drug, may be composed of several other excipient ingredients. The marking stating “500 mg” may be a blend of 6 other colors because FDA will not have approved that unique marking color found on most tablets or in most elixirs or creams. If the marking is comprised of 6 separate colors and the manufacturer sources these colors from 10 different suppliers then you suddenly have 60 suppliers you have to tell FDA about in the drug listing for that one drug! Now multiply that for the binder, the filler, the coating, and all the other excipients in the drug and you’re looking at potentially hundreds of excipient suppliers that FDA now wants you to tell them about when you list your drug product. For each of those suppliers FDA wants to know:
- Name of company
- Unique facility identifier
- Point of contact
- Email address
If you were thinking about taking a vacation this year, cancel it. You’re going to be getting cozy with some spreadsheets. But why would FDA want this information? Apparently, to “ensure the safety and security of the drug supply chain,” according to Margaret Hamburg and FDA. This is another case of FDA looking busy but not advancing actual drug or supply chain safety. FDA will be making it substantially more difficult to list a drug, yet will produce the regulatory benefit equivalent to polishing doorknobs. Does FDA really intend to inspect all of these newly listed facilities? Forget it. If a company is counterfeiting drugs, do you think they’ll bother providing accurate information for their excipient suppliers? So FDA appears to be advancing supply chain safety but in reality will be merely increasing the regulatory burden with no benefit.