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Background and Analysis Counter to DiCola v. FDA, the US Federal Courts rendered a decision in 1998 that allows permanently debarred individuals to come back to the pharmaceutical industry and work on projects right up to the point where the firm holds a pending or approved drug product application. This was a drastic reversal of the Federal Court's previously strict interpretation of the FDA's "In Any Capacity" prohibition. The Food and Drug Administration has failed to resolve this matter; the first known case of a permanently debarred individual crossing the line. On December 16, 1998 the FDA issued "Violation of Debarment" letters to the involved individual and firm. Critical FOIA documents have not been released by FDA. Subsequently, the FDA added "aka, Lau, Daphne" to Internet Debarment List. Then, ORA had to stop yet another return to the industry. PDF referring to L&L Technologies. FDA has advised drug manufacturers to update their 21 USC 335a(k) certifications from all suppliers of goods and services. The Court rulings ignored the applicable (and very broad) definition that previously allowed the FDA to keep debarred individuals at a safe distance. As specifically stated in 21 USC 321(dd)… "For the purposes of sections 335a and 335b of this title, the term "drug product" means a drug subject to regulation under section 355, 357, 360b, or 382 of this title or under section 262 of title 42." The recent FDA letter shows just how badly the District Court erred when it relied on the narrow 21CFR definition. In fact, 21 CFR § 210.3(4) does not define "drug product application". The term is defined in 21 USC 321 in very broad terms. A prohibited act would apparently include all drug projects where an application is submitted for approval by FDA. The Courts apparently couldn't see that the Generic Drug Enforcement Act's legislative intent was to protect the integrity of the drug approval process. The Court of Appeals going as far as to liken the relevant 21 USC definition to "grasping at straws". The Generic Drug Enforcement Act is to protect the integrity of the drug approval process. The complex interaction of companies that take part in that process is clearly stated in the FDA violation of debarment letter issued to Ms. Pai: |
| "Here, it is not sufficient to consider only whether your employer, InterChem, has approved or pending drug product applications. The pertinent query is whether InterChem provides services in any capacity to a person with such applications. InterChem provides services to the drug industry in that it assists in identifying drugs to be introduced into the generic market and locating companies to market such drugs." |
| Quoting the September 1998 draft guidance on Submitting Debarment Certification Statements: |
| "The agency has interpreted "services in any capacity" to mean any service provided to the drug applicant, regardless of whether related to drug regulation. That means a debarred individual may not provide non-drug-related services to a drug product applicant (e.g., as a landscaper, a computer software supplier, an accountant, a telephone repair person, a janitor, an interior decorator, a landlord) without violating debarment." |
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For more, please contact:
Food and Drug Administration Rm. 14-90, HFC-1 5600 Fishers Lane Rockville, MD 20857 (301) 827-3101 FAX (301) 443-6591 |