FDA's Risk Evaluation and Mitigation Strategies (REMS): Effective and efficient safety tools or process poltergeist?

Food and Drug Law Journal

Volumn 66, Issue 4, 2011, Pages

  Wilson, Andrew ^a,b   Milne, Christopher Paul ^a  

^a TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b BRANDEIS UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

FENTANYL; OPIATE; VIGABATRIN;

CLINICAL PRACTICE; COMMERCIAL PHENOMENA; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HEALTH CARE COST; HEALTH CARE DELIVERY; HEALTH CARE PERSONNEL; HEALTH CARE SYSTEM; HOSPICE CARE; HOSPITAL DEPARTMENT; HUMAN; LAW; MEDICAL DOCUMENTATION; MEDICAL EDUCATION; PATIENT ADVOCACY; PATIENT COUNSELING; PATIENT SAFETY; PHARMACIST; PHARMACY BENEFIT MANAGER; REVIEW; RISK ASSESSMENT; RISK EVALUATION AND MITIGATION STRATEGY; SAFETY; TREATMENT DURATION; WORK ENVIRONMENT;

DRUG APPROVAL; HUMANS; LEGISLATION, DRUG; RISK ASSESSMENT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84881560661     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (21)

1. Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110-85, § 901 (codified at 21 U.S.C. § 355-1 (2007)). This Act, known commonly as FDAAA, is also the fourth iteration of the Prescription Drug User Fee Act, known as PDUFA IV, which will sunset on September 30, 2012.
2. Laura B Faden, Christopher-Paul Milne, Pharmacovigilance activities in the United States, European Union and Japan: Harmonic convergence or convergent evolution? 63 FOOD & DRUG LAW J. 683 (2008).
3. Deborah B. Leiderman, Risk management of drug products and the U.S. Food and Drug Administration: Evolution and context. 105S Drug Alcohol & Dependence S9-S13 (2009).
4. Michael McCaughan, REMS 2.0: FDA refining new drug safely tools. 4 THE RPM REPORT (Nov 2010), available at http://sis.windhover.com/buy/abstract.php? id=2010500131.
5. Food and Drug Administration, Approved Risk Evaluation and Mitigation Strategies (REMS), [REMS website] available at http://www.fda.gov/Drugs/ DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm.
6. See FDA Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Draft Guidance, September 2009), available at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ default.htm. Although the FDA issued draft guidance on REMS in September 2009 outlining the requirements in more detail, the public comment period remains ongoing.
7. See FDA Website, Medication Guides, available at: http://www.fda.gov/ Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ ucm111350.htm. Accessed: Feb. 18, 2011.
8. FDAAA,Sec. 505-1(b)(4). FDAAA defines a "serious adverse drug experience" as any adverse event that results in death, immediate risk of death, hospitalization or extension of hospitalization, incapacity or disruption of normal life functions, a congenital anomaly or birth defect.
9. FDAAA Sec. 505-1 (f)(2) (A).
10. FDA Draft Guidance (2009), supra note 6.
11. See generally Kaitin KI (ed.), U.S.healthcare stakeholders uncertain on benefits of risk evaluation strategy (Jan/Feb 2011), Tufts Center for the Study of Drug Development Impact Report.
12. FDA REMS website, supra note 5.
13. Sue Sutter, Early REMS assessments show room for improvement in medguides. THE PINK SHEET (Nov. 29, 2010), (Vol.72, No. 48, Page 7).
14. Guidance for Industry: Medication Guides - Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS), (Draft, February 2011), U.S. Department of Health and Human Services, Food and Drug Administration, available at http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM244570.pdf
15. Sue Sutter, CDER Eyes prioritization, Timely Resolution of Post-Marketing Safety Issues, THE PINK SHEET (Nov. 29, 2010), (Vol. 72, No. 48, Page 11).
16. PDUFA V will be the fifth iteration of the Prescription Drug User Fee Act, which was originally enacted in 1992 and has been reauthorized every five years, with the expectation that it will be renewed as PDUFA V and become governing law as of October 1, 2012.
17. Steve Usdin, PDUFA: A lot of Talk, BIOCENTURY: THE BERNSTEIN REPORT ON BIOBUSINESS (June 6, 2011), available at http://www.biocentury.com/biotech- pharma-news/cover-story/2011-06-06/details-on-fda-industry-deal-for-pdufa-v-its- about-meetings-not-money-a1.
18. Cathy Dombrowski, The Limits of REMS: Opioid Debate Shows Shortcomings of New FDA Powers, THE PINK SHEET (August 2, 2010), (Vol. 72, No. 31, Page 27).
19. CDER Eyes Prioritization, supra note 17, at 9.
20. Derrick Gingery, Antibiotics Need REMS for Public, Not Patient, Safety Reasons, IDSA Says, THE PINK SHEET (September 13, 2010), (Vol. 72, No. 37, Page 15).
21. Usdin 2011, supra note 18.