In a move that has me puzzled, the Government’s award of the contract to a company that does not appear on the FDA’s list of DMF holders, and is not found as a holder of any approved ANDA or NDA in the FDA’s Orange Book seems a bit strange. According to a FOX news story (here ), Phlow Corporation will be tasked with obtaining and making active pharmaceutical ingredients (APIs) for a national stockpile of shortage drug active ingredients. The report states:
“HHS said the contract is with Phlow Corporation of Richmond and will provide ‘immediate U.S.-based capacity’ to produce active pharmaceutical ingredients and chemical compounds for ingredients to make ‘critical medicines to help alleviate or prevent drug shortages‘ during the COVID-19 crisis. The drug ingredients are expected to be manufactured at facilities in the U.S., including a new facility that will be built in Virginia.”
Good idea? Maybe, but there is a lot of regulatory implications that have not been addressed by any story I have read on this issue.
- Was this a competitively bid contract? I know in national emergencies there are powers that the government has that may sidestep this requirement, but I think it is a good thing to ask.
- Once the facility that makes the APIs is up and running, it must be inspected by FDA and then they will have to file a DMF with the Agency for each of the APIs they intend to market.
- ANDA applicants that have an approved application will need to supplement their applications with the new sources of supply.
- Pending or new ANDA applicants seeking approval for the use of the Phlow API will need to amend their application or wait until their application is approved and supplement for the alternate source of supply.
- Approved ANDA applicants will need to make a batch of the drug product with 3 months of accelerated and room temperature stability along with associated analytical testing on the API and drug product, reference the DMF for the API, and provide all relevant information regarding the batch of finished pharmaceutical product as a supplement to their ANDA.
- New ANDA applicants will be required to produce 3 batches of drug product using at least 2 different lots of APIs and provide 6 months accelerated and room temperature stability data along with the other necessary information for application approval.
- How will this contract award impact competition in the currently existing supply chain?
- Although there is an indication that Phlow will use other firms like Civica Rx, does the contract outline who gets access to the US-made APIs to make finished product in a shortage situation?
- What happens after the COVID-19 crisis is over?
These are just a few of the questions that come to mind. If anyone should have other thoughts on this matter or any other related issues, please forward them along to us at Lachman’s mailbox, LCS@lachmanconsultants.com