The daughter said herself that someone has to pay.
The taxpayers are going to pay. Either through a tax subsidy to a known GMP violator with no monetary motivation to make sure the drug is safe like Jacobus, or to a company like CPRX who has every motivation to make sure the drug is made properly and safely.
That would be weird to award Breakthrough Therapy status to CPRX for a drug that was already approved.
Why would CPRX spend so much money proving a more stable compound salt of 3,4 DAP if it was already approved?
The reason is because it is not already approved and Jacobus wasn't going to spend the money to approve their version probably because that would cost money and they could circumvent the FDA process for 20+years by using it as a tax write off instead.
Safety is a big issue.
EPARTMENT OF HEALTH & HUMAN SERVICES
.: Mid-Atlantic Region
Food and Drug Administration
J Waterview Corporate Center
Telephone (201) 331–2906 10 Waterview Blvd., 3rd Floor
F’arsippany, NJ 07054
October 1, 1997
Dr. David P. Jacobus
Jacobus Pharmaceutical Co. , Inc.
37 Cleveland Lane, PO Box 5290
Princeton, New Jersey 08540
File No.: 97-NWJ-52
Dear Dr. Jacobus:
During an inspection of your Manufacturing facility located at
Schalks Crossing Road, Plainsboro, New Jersey 08536, between June
n-July 3, 1997, one of our invest~gators documented significant
deviations from current Good Manufacturing Practices (cGMPs) in the
manufacture of Active Pharmaceutical Ingredients (APIs) and
The aforementioned inspection revealed that API products and
finished pharmaceuticals manufactured and released at this facility
are considered adulterated within the meaning of section 501(a) (2)
(B) of the Federal Food, Drug & Cosmetic Act (the Act).
Although the GMP regulations under Title 21 Code of Federal
Regulations, Parts 210 and 211, are used as guidelines in the API
industry, Section 501 (a) (2) (B) of the Act requires that all
drugs be manufactured, processed, packed, and held in accordance
with cGMPs. No distinction is made between active pharmaceutical
ingredients and finished pharmaceuticals. Failure to comply with
cGMPs constitutes a failure to comply with requirements of the Act.