#ACIcGMP ACI’s Legal, Quality, Regulatory, and Compliance Forum on current Good Manufacturing Practices Douglas B. Farquhar, Director Hyman, Phelps & McNamara PC Washington, D.C. International Inspections and Their Undesirable Consequences January 23-24, 2014 Tweeting about this conference? HYMAN , PHELPS & MCNAMARA, P.C.
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International Inspections and Their Undesirable Consequences · current Good Manufacturing Practices Douglas B. Farquhar, Director Hyman, Phelps & McNamara PC Washington, D.C. International
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#ACIcGMP
ACI’s Legal, Quality, Regulatory, and Compliance Forum on current Good Manufacturing Practices
Douglas B. Farquhar, Director
Hyman, Phelps & McNamara PC
Washington, D.C.
International Inspections and Their Undesirable Consequences
January 23-24, 2014
Tweeting about this conference?
HYMAN, PHELPS & MCNAMARA, P.C.
#ACIcGMP
Adverse Regulatory Consequences from cGMP Inspections
• Warning Letters
• Publicity
• Import Detentions
• Withdrawal of Drug Approvals
• Drug Application Review Holds
• “Forced” Recalls
• Application Integrity Policy
• Seizures
• Consent Decrees
• Injunctions
• Debarment/Exclusion
• Criminal Prosecution
#ACIcGMP
Most cGMP Warning Letters for Human Drugs Issued to Foreign Companies
12 Warning Letters issued for human drug cGMP violations in last six months of 2013
8 of those Warning Letters issued based on inspections of drug
manufacturing facilities in foreign countries (6 in India) 3 of those Warning Letters issued to plants in Continental U.S.,
one for plant in Puerto Rico
-- FDA Warning Letters issued July 1, 2013 through December 31, 2013 for drug cGMP violations and posted on FDA website
as of January 16, 2014, excluding compounding pharmacies
#ACIcGMP
Warning Letters Issued after Foreign Inspections (sample)
#ACIcGMP
FDA International Inspectional Focus
• FDA Officials have said 80 percent of drugs distributed in U.S. are either manufactured outside U.S. or manufactured using an Active Pharmaceutical Ingredient from foreign countries
#ACIcGMP
FDA Inspection Force in India “The US Food and Drug Administration (USFDA) is increasing its inspections of facilities of drug makers in India, the second largest provider of finished dose products to the US, to ensure compliance of approved manufacturing norms. “The US health regulator, which has been cracking the whip against many Indian pharmaceutical firms, including Ranbaxy Laboratories and Wockhardt, is also recruiting and training additional drugs investigators in India. “‘In March 2013, the (US) FDA received approval from the Indian government to add seven additional drugs investigators in India. We are currently recruiting and training staff for these positions,’ a spokesperson for USFDA, Christopher C Kelly, said in an emailed response. “USFDA's presence in India is being increased to 19 from 12 American staff based in-country, including 10 dedicated specifically to medical products. Other staff include foods and devices inspectors, and policy analysts.”
Import Alerts – Statute • 21 U.S. Code §381. Imports and exports
• (a) The Secretary of the Treasury [meaning Customs] shall deliver to the Secretary of Health and Human Services [meaning FDA] . . . samples of . . . drugs, devices. . . and cosmetics which are being imported or offered for import into the United States, giving notice thereof to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. The Secretary of Health and Human Services shall furnish to the Secretary of the Treasury a list of establishments registered pursuant to subsection (i) of section 360 or section 387e(h) of this title and shall request that if any drugs, devices, or tobacco products manufactured, prepared, propagated, compounded, or processed in an establishment not so registered are imported or offered for import into the United States, samples of such drugs, devices, or tobacco products be delivered to the Secretary of Health and Human Services, with notice of such delivery to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony.
#ACIcGMP
Import Alerts – Statute
• 21 U.S. Code §381. Imports and exports (cont.)
• (a) . . . If it appears from the examination of such samples or otherwise that (1) such article has been manufactured, processed, or packed under insanitary conditions or, in the case of a device, the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of section 360j(f) of this title, or (2) such article is forbidden or restricted in sale in the country in which it was produced or from which it was exported, or (3) such article is adulterated, misbranded, or in violation of section 355 of this title, or prohibited from introduction or delivery for introduction into interstate commerce under section 331(ll) of this title, or (4) the recordkeeping requirements under section 2223 of this title (other than the requirements under subsection (f) of such section) have not been complied with regarding such article, then such article shall be refused admission, except as provided in subsection (b) of this section.