+ Site Statistics
+ Search Articles
+ PDF Full Text Service
How our service works
Request PDF Full Text
+ Follow Us
Follow on Facebook
Follow on Twitter
Follow on LinkedIn
+ Subscribe to Site Feeds
Most Shared
PDF Full Text
+ Translate
+ Recently Requested

How the US Food and Drug Administration can solve the prescription drug shortage problem



How the US Food and Drug Administration can solve the prescription drug shortage problem



American Journal of Public Health 103(5): E10-E14



Drug shortages are threatening care quality and cost-containment efforts. I describe the pharmaceutical marketplace changes that have caused the problem, and propose new policies to solve it, through changing incentives for producers and purchasers. I propose a grading scheme for the Food and Drug Administration when it inspects manufacturing facilities in the United States and abroad. The inspections' focus would change from closing unsafe plants to improving production process quality, reducing the likelihood that plants will be closed-the most frequent cause of drug shortages.

Please choose payment method:






(PDF emailed within 0-6 h: $19.90)

Accession: 053597355

Download citation: RISBibTeXText

PMID: 23488502

DOI: 10.2105/ajph.2013.301239


Related references

Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; policies, requirements, and administrative procedures. Food and Drug Administration, HHS. Final rule. Federal Register 64(232): 67720-67763, 2000

Off-label antidepressant prescription in pediatric outpatients based on China Food and Drug Administration and Food and Drug Administration regulations: a Chinese retrospective study. International Clinical Psychopharmacology 33(3): 172-179, 2018

The Prescription Drug User Fee Act: is a faster Food and Drug Administration always a better Food and Drug Administration?. Food and Drug Law Journal 60(2): 261-338, 2005

Food and Drug Administration Modernization Act of 1997; list of documents issued by the Food and Drug Administration that apply to medical devices regulated by the Center for Biologics Evaluation and Research. Food and Drug Administration, HHS. Notice. Federal Register 64(79): 20312-3, 1999

Prescription Drug Promotion from 2001-2014: Data from the U.S. Food and Drug Administration. Plos One 11(5): E0155035, 2017

High Prescription Drug Prices and the Influence of the Food and Drug Administration: In Response. Mayo Clinic Proceedings 79(4): 569-570, 2004

High prescription drug prices and the influence of the Food and Drug Administration. Mayo Clinic Proceedings 79(4): 569; Discussion 569-70, 2004

Planning In The Food And Drug Administration For Regulation Of Prescription Drug Advertising. Current Therapeutic Research, Clinical and Experimental 7: 332-336, 1965

The Food and Drug Administration's regulation of prescription drug manufacturer speech: a First Amendment analysis. Food and Drug Law Journal 58(3): 365-437, 2003

Association of food and drug officials food and drug administration model food salvage code an approach to the problem. Journal Of Food Protection: 913, 1985

Are Food and Drug Administration prescription drug safety plans working? A case study of isotretinoin. Pharmacoepidemiology and Drug Safety 22(12): 1258-1262, 2013

Prescription drug products; patient package insert requirements--Food and Drug Administration. Final rule. Federal Register 46(1): 28-30, 1980

Food and Drug Administration--Prescription drug products; patient package inserts requirements. Final rule. Federal Register 45(179 Pt 2): 60754-60784, 1980

Clinical Evidence Supporting US Food and Drug Administration Approval of Otolaryngologic Prescription Drug Indications, 2005-2014. Otolaryngology--Head and Neck Surgery 156(4): 683-692, 2017

Prescription drug products; revocation of patient package insert requirements--Food and Drug Administration. Final rule. Federal Register 47(173): 39147-39155, 1982