Drug Shortages in US

When I see a panic expressed by press it means the issue is real or when there is smoke after the fire.?

In the case of drug shortages it is the Fire that has been smoldering for a long time but is spreading and our CONGRESS/Government has failed.?

https://www.raps.org/news-and-articles/news-articles/2023/8/lawmakers,-concerned-about-shortages,-urge-fda-to?mkt_tok=MjU5LVdMVS04MDkAAAGNXGNQHESVsDn8D0p-tGPRAfizG9D5FvxTNMPyxAwit8xkk0LwpiiHeDDbVG6AY-9JxDkEzAwSxfarhONHdgizmCNA6JgavjrPTvHRk4wK

Congress?is asking FDA to invoke Drug Supply Chain Security Act) is like starting from scratch when FDA does not know what it is up against. Vested interests: PBMs (pharmacy benefit managers) and GPO ( group purchasing organizations) have no interest in bringing manufacturing home as it would impede their profits. FDA whose mission is to prolong the approval process when it talks about simplification but monitoring?shortages?through electronic monitoring i.e. another form of?bureaucracy where it has no?experience.

Following is my perspective.?

Drug shortage?issue has been an ongoing, looming, issue for many years but has been kicked down the road as if it will disappear with twitch of a nose.

It is ironic that US Legislators (Congress and Senate) have had multiple hearings on the issues. Members of FDA and others have presented plans that have been meaningless as they have never presented any viable plan even after multiple Executive orders have been issued. They have ignored THREE EXECUTIVE ORDERS (EO 13588, 13944 and?https://www.whitehouse.gov/briefing-room/presidential-actions/2021/02/24/executive-order-on-americas-supply-chains/).?

NAS (National Academy of Science, Engineering and Medicine) proposed a most ridiculous suggestion of increasing US drug dependence?https://bit.ly/3NUxhsP?by creating better supply relationships with foreign countries. It is ironic that the current FDA Commissioner, Dr. Robert?Califf?was part of the NAS Task Force that?made the relationship suggestions. It quoted FDA’s pet projects as means to reduce shortages when FDA does not know what they are and how to implement them as they have never justified,?developed and or commercialized any profit making process/s.

I am told that there is a secret taskforce under the current administration to address the issue. If it does not have the right players, nothing will change. US will be held hostage for its healthcare.

Bottom line is no one will address the issue as they do not know how and what all is needed. They will be stuck in bureaucratic quagmire established by USFDA. No company will invest in plants if they cannot get a reasonable return on their investment. Without fast track ANDA approval process nothing meaningful will happen.

Unless a serious and concerted effort is made, no much will change. Actually time has run out on US fortunes when it comes addressing drug shortages. US has the knowhow and knowledge to do almost anything but is not able to shore up its rudimentary needs of its citizen’s health.

It is time US wakes up and addresses the issue. USFDA has totally failed to improve its systems to bring manufacturing home.?

Following are some of the potential ways to address the issue. They will bring generic pharma manufacturing home and improve employment.

1. ONE PAGE Road Map to Reduce Drug Shortages, Assure Quality and Improve Affordability?https://bit.ly/34RYypH?December 6, 2019
2. A road map for driving pharmaceutical manufacturing back to the USA by 2025?https://bit.ly/3nxOlIz?October 8, 2020?
3. There is a saying that thundering clouds seldom rain. Does this apply to pharmaceutical manufacturing coming back to USA, especially for?the generic and essential drugs is anyone’s wild guess? But it seems that this proverb could become a fact. In this perspective, an attempt is made to outline what has happened in the last ten years of drug shortages, high prices and the ongoing?rumble of ‘bring manufacturing home’.??
4. US’s Self Sufficiency for Generic Drugs: A Supply Dilemma and Potential Solutions?https://bit.ly/3KbTSzP?March 31, 2022

Monies (in excess of $800 millions) have been given to Phlow Corp [https://www.politico.com/news/2022/07/09/trump-era-federal-covid-contract-recipient-has-yet-to-meet-major-deadlines-00040401] by US taxpayers to address shortages. Company has no FDA approved plant, no FDA approved product/s and are in relationship with a South Korean comapny. It is a front for scam. In fact instead of filling the need they have changed their mission and are looking for work.?

Please let me know if there are any questions. Thank you!?

Girish Malhotra, PE