This is an abbreviated post of my previous blog post (1).
REVISIONS INCLUDE 45 DAYS APPROVAL TIME OF THE GENERIC DRUGS FROM EARLIER 90 DAYS AND LOWER FILING FEES.
For more than two decades US Government has been aware of potential political and strategic supply chain issues related to the continued sourcing of the generic drugs. In spite of many congressional hearings and Executive Orders to mitigate the issues, dependence still exists. Basically no viable solution has been proposed.
Looking at the landscape, US Food and Drug Administration (FDA) and Pharmacy Benefit Managers (PBMs) have stood in the way of bringing generic drug manufacturing home. There may be disagreement on this but in my opinion US FDA’s time approval consuming system, fraught with “its analysis paralysis” results in approval delays. It is litigious and any benefits are not known to the consumers. Hatch-Waxman Act intended to facilitate generic drug supplies has become a way to delay their availability.
Fascinating that FDA has had the capability to change and simplify the approval landscape but squarely has done nothing. My conjecture: FDA’s major focus is on approval of new drugs. Generic approvals are just an obligation to assure “out of patent” and imported drugs being sold meet US safety and performance standards. Their prolonged approval times have stand in the way of them being manufactured in USA. No investor will invest in a US based generic plant with an unknown ROI (return on investment) timetable. My conclusion is that no one at FDA understands this. This has to change. No effort has been made to simplify their approval times. Discussed process is simple and doable. It makes an excellent case of “Nondestructive Creation”. However, it will be passionately resisted by everyone involved with approval of pharmaceuticals.
CDER (Center for Drug Evaluation and Research) at FDA has to be split in BRAND (NDA) and GENERIC (ANDA) Approval Groups. It can be done in three months or less. Each will operate as an independent business unit. FDA’s internal knowledge of methods will help and be of great value. Their performance will be measured by the number of filled and approved drugs in each fiscal year with no carry overs as is done today.
Every brand company whose patent expires in five years will make available in the public domain except for their manufacturing process product details (solubilities, bioequivalence, toxicity, all of the relevant information etc.) that are considered necessary for FDA approval. Due to vested interests FDA, Patent Attorneys, Legislators and Brand companies will resist. Unless US government intervenes no change will happen. Each filing company can develop and commercialize their own manufacturing process to meet specifications detailed in the mock application.
Each group will be responsible for approval of their respective drug categories. ANDA approval time will be 45 days from the day of filing. If no action is taken for 45+ days, it will result in automatic approval of the generic drug. If any marketed approved drug does not meet established expiring brand quality standards, addressed later, company will be banned for selling drugs in USA. Seeing what ANDA group can accomplish, my conjecture is that NDA approval time table will become shorter than the current times, a benefit for the brand companies.
ANDA group at CDER fill a mock application documenting every detail for each “going off patented” drug. Each company interested in producing the drug in USA will replicate the information if they want their generic drug approved. These applications will also be a test of FDA’s own capabilities, credibility and effectiveness to understand manufacturing processes, its own review processes and what to expect from the companies.
Company wanting to produce the generic drug can commercialize their own process. They will have to make sure that they can produce (replicate) the brand, now generic, product in every detail. It is expected that FDA’s ANDA group will understand the submitted manufacturing process. They can do an unannounced site inspections. 45 days does not give FDA sufficient time to inspect the manufacturing site.
With respect to company’s manufacturing process, equipment and test methods FDA will have to rely on random sampling of the product and have it tested by an approved independent laboratory to ensure product meets quality. Any deviation from the agreed standard would be subject to company stopping production and stop sales in USA for six months till the issue is remediated. Any repeat noncompliance would result in complete shutdown of the company. It is expected that the reduced approval time will result in lower ANDA review fees an added incentive for the companies to establish manufacturing in USA.
All of the above might look ominous and challenging. It is not as every experienced chemical engineer and chemist will have all of the information available. It is up to FDA and the interested company to capitalize on the opportunity.
USA government for its part will have to assure that Medicare, Medicaid and Veterans Administration buy their generic drugs from US manufacturers. PBMs would not be allowed to distribute domestically manufactured generic drugs. Task at hand is challenging and USA has never shrugged from any challenges.
Girish Malhotra, PE
President
EPCOT International
Reference:
1. Malhotra, Girish: For Domestic Pharma Manufacturing: Reorganize CDER November 6, 2025
