Post-Marketing Surveillance of Prescription Drug Safety: Past, Present, and Future

Click to increase image sizeClick to decrease image size

Acknowledgments

Dr. Chen is Assistant Professor, Department of Health Services Policy and Management, Arnold School of Public Health at University of South Carolina. He is an applied economist whose research focuses on the impact of incentives in health care organizations on provider and patient behavior. Dr. Yang is Assistant Professor, Department of Health Administration and Policy, College of Health and Human Services at George Mason University. Previously a researcher at the Massachusetts Institute of Technology and CDC-NCHS/AcademyHealth Health Policy Fellow, his research draws upon his background as a lawyer, policy analyst, and health services researcher. Please address correspondence to Dr. Chen at 800 Sumter Street Suite 116F, Columbia, SC 29208 or via e-mail at [email protected].

Notes

Eric J. Topol, Failing the Public Health—Rofecoxib, Merck, and the FDA, 351 New Eng. J. Med. 1707, 1707 (2004). “Pharmacoepidemiology is the ‘study of the use and effects of drugs in large numbers of persons.’” Esmond D. Nwokeji et al., 71 Am. J. Pharmaceutical Educ. 1 (2007), available at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1959224/pdf/ajpe80.pdf.

Meredith M. Wadman, Drug Safety Special: The Safety Catch, 434 Nature 554, 554 (2005).

Bruce M. Psaty & Curt D. Furberg, The Record on Rosiglitazone and the Risk of Myocardial Infarction, 357 New Eng. J. Med. 67, 68 (2007); Bruce M. Psaty & Curt D. Furberg, Rosiglitazone and Cardiovascular Risk, 356 New Eng. J. Med. 2522, 2523 (2007).

Psaty & Furberg, The Record, supra note 3, at 69.

Safety Announcement, FDA, FDA Drug Safety Communication: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandament, and Avandryl (May 18, 2011), http://www.fda.gov/Drugs/DrugSafety/ucm255005.htm.

Press Release, FDA, FDA Significantly Restricts Access to the Diabetes Drug Avandia (Sept. 23, 2010), http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm226975.htm.

Robert A. Raschke et al., A Computer Alert System to Prevent Injury from Adverse Drug Events, 280 J.A.M.A. 1317, 1317 (1998).

Fiscal Year 2008 FDA Budget Request: Hearings Before the Senate Committee on Appropriations, Subcommittee on Agriculture, Rural Development, Food Administration, and Related Agencies, 110th Cong. (2007) (statement of Andrew C. von Eschenbach), available at http://www.fda.gov/NewsEvents/Testimony/ucm154237.htm.

2009 Annual Report of the Boards of Trustees of the Federal Hospital Insurance and Federal Supplementary Medical Insurance Trust Funds 5 (2009), available at http://www.cms.hhs.gov/reportstrustfunds/downloads/tr2009.pdf.

Ben Hirschler, Drug R&D Spending Fell in 2010, and Heading Lower (June 26, 2011), http://www.reuters.com/article/2011/06/26/pharmaceuticals-rd-idUSL6E7HO1BL20110626.

Cong. Budget Office, Promotional Spending for Prescription Drugs 2 (2009), http://www.cbo.gov/publication/41216.

Brian L. Strom, How the US Drug Safety System Should Be Changed, 295 J.A.M.A. 2072, 2073 (2006).

FDA, AERS Patient Outcomes by Year (Dec. 31, 2010), http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070461.htm.

Gerald Gianutsos, Identifying Factors that Cause Pharmacy Errors (Dec. 1, 2008), http://www.uspharmacist.com/continuing_education/ceviewtest/lessonid/105916/.

Jerry H. Gurwitz et al., Incidence and Preventability of Adverse Drug Events Among Older Persons in the Ambulatory Setting, 289 J.A.M.A. 1107, 1107 (2003); Alan J. Forster et al., Adverse Drug Events Occurring Following Hospital Discharge, 20 J. Gen. Internal Med. 317, 317 (2005).

Karen E. Lasser et al., Timing of New Black Box Warnings and Withdrawals for Prescription Medications, 287 J.A.M.A. 2215, 2218 (2002).

Ruth B. Merkatz et al., Women in Clinical Trials of New Drugs—A Change in Food and Drug Administration Policy, 329 New Eng. J. Med. 292, 293 (1993).

Strom, supra note 12, at 2072.

Id.

Chunliu Zhan & Marlene R. Miller, Administrative Data Based Patient Safety Research: A Critical Review, 12 Quality & Safety Health Care ii58, ii62 (2003).

Samuel Shapiro, The Role of Automated Record Linkage in the Postmarketing Surveillance of Drug Safety: A Critique, 46 Clin. Pharmacology & Therapeutics 371 (1989).

Susan Okie, Safety in Numbers—Monitoring Risk in Approved Drugs, 352 New Eng. J. Med. 1173, 1174 (2005).

See Anne Trontell, Expecting the Unexpected—Drug Safety, Pharmacovigilance, and the Prepared Mind, 351 New Eng. J. Med. 1385, 1385 (2004). The author points out that unforeseen drug interactions with coexisting clinical conditions or other drug therapies may go unstudied in clinical drug trials because trials are comprised of several thousand people treated in tightly controlled manner. See Strom, supra note 12, at 2073. The author notes that the use of carefully selected patients for drug trials creates a selection bias against “real-life” patients.

Wadman, supra note 2, at 556.

FDA, FY 2009 PDUFA Financial Report 1 (2009), available at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/FinancialReports/PDUFA/UCM226679.pdf.

Kathlyn Stone, 2012 Renewal of the Prescription Drug User Fee Act, (2013) http://pharma.about.com/od/FDA/a/2012-Renewal-Of-The-Prescription-Drug-User-Fee-Act-Pdufa.htm.

FDA, FY 2009 PDUFA Financial Report, supra note 25, at 22.

Susan Okie, supra note 22, at 1173–74.

Id.

Phil B. Fontanarosa et al., Postmarketing Surveillance—Lack of Vigilance, Lack of Trust, 292 J.A.M.A. 2647, 2647 (2004).

Ernst R. Berndt et al., Assessing the Impacts of the Prescription Drug User Fee Acts (PDUFA) on the FDA Approval Process, 1–5 (Nat’l Bureau of Econ. Research, Working Paper No. 10822, 2004).

Karen Peart, In Drug-Approval Race, U.S. FDA Ahead of Canada, Europe, Yale News, May 16, 2012, http://news.yale.edu/2012/05/16/drug-approval-race-us-fda-ahead-canada-europe.

Bruce M. Psaty & Sheila P. Burke, Institute of Medicine on Drug Safety, 355 New Eng. J. Med. 1753, 1753 (2006).

Gardiner Harris, At F.D.A., Strong Drug Ties and Less Monitoring, N.Y. Times, Dec. 6, 2004, http://www.nytimes.com/2004/12/06/health/06fda.html?_r=1.

Fontanarosa et al., supra note 30, at 2647.

John Abraham & Courtney Davis, A Comparative Analysis of Drug Safety Withdrawals in the UK and the US (1971–1992): Implications for Current Regulatory Thinking and Policy, 61 Soc. Sci. & Med. 881 (2005).

Daniel Carpenter et al., Drug-Review Deadlines and Safety Problems, 358 New Eng. J. Med. 1359 (2008).

Mary K. Olson, The Risk We Bear: The Effects of Review Speed and Industry User Fees on New Drug Safety, 27 J. Health Econ. 175 (2008); see also Henry Grabowski & Y. Richard Wang, Do Faster Food and Drug Administration Drug Reviews Adversely Affect Patient Safety? An Analysis of the 1992 Prescription Drug User Fee Act, 51 J.L. & Econ. 377, 378 (2008).

Grabowski & Wang, supra note 38, at 378.

Wadman, supra note 2, at 555.

Id. at 556.

Id.

Id.

Id.

See generally Psaty & Burke, supra note 33.

Id. at 1753.

Id.

Id. at 1754.

Lucian L. Leape, Reporting of Adverse Events, 347 New Eng. J. Med. 1633, 1634 (2002).

Grabowski & Wang, supra note 38, at 386.

See Leape, supra note 49, at 1633.

Fontanarosa et al., supra note 30, at 2649.

Sarah L. Zielinski, FDA Attempting to Overcome Major Roadblocks in Monitoring Drug Safety, 97 J. Nat’l Cancer Inst. 872, 872 (2005).

Psaty & Burke, supra note 33, at 1754.

Psaty & Furberg, The Record, supra note 3, at 68.

Fontanarosa et al., supra note 30, at 2647; see Wadman, supra note 2, at 554.

Zielinski, supra note 53, at 873.

Psaty & Burke, supra note 33, at 1753.

See Henry A. Waxman, The Lessons of Vioxx—Drug Safety and Sales, 352 New Eng. J. Med. 2576 (2005).

See generally Katherine A. Helm, Protecting Public Health from Outside the Physician's Office: A Century of FDA Regulation from Drug Safety Labeling to Off-label Drug Promotion, 18 Fordham Intell. Property, Media & Ent. L.J. 117 (2007); see also Carolyn Clancy, Off-Label Drugs: What You Need to Know, Agency for Healthcare Research and Quality (Apr. 21, 2009), http://www.ahrq.gov/news/columns/navigating-the-health-care-system/042109.html.

Aaron S. Kesselheim & Michelle M. Mello, Confidentiality Laws and Secrecy in Medical Research: Improving Public Access to Data on Drug Safety, 26 Health Aff. 483, 483–84 (2007).

FDA, The Future of Drug Safety—Promoting and Protecting the Health of the Public—FDA's Response to the Instittue of Medicine's 2006 Report 19 (2007), available at http://www.fda.gov/downloads/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm171627.pdf.

Bruce M. Psaty & David Korn, Congress Responds to the IOM Drug Safety Report—In Full, 298 J.A.M.A. 2185, 2185–87 (2007); Psaty & Burke, supra note 33, at 1755; see generally Wadman, supra note 2.

Wadman, supra note 2, at 556.

Psaty & Burke, supra note 33, at 1755; see generally Strom, supra note 12.

See generally Inst. Med., The Future of Drug Safety: Promoting and Protecting the Health of the Public (2006).

Id. at 10.

Okie, supra note 22, at 1175; Fontanarosa et al., supra note 30, at 2649; Wayne A. Ray & C. Michael Stein, Reform of Drug Regulation—Beyond an Independent Drug-Safety Board, 354 New Eng. J. Med. 194, 196 (2006); Alastair J.J. Wood et al., Making Medicines Safer—The Need for an Independent Drug Safety Board, 339 New Eng. J. Med. 1851, 1851 (1998).

Inst. Med., supra note 66, at 6.

Psaty & Burke, supra note 33, at 1755.

Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110–85, § 901, 121 Stat. 823 (2007).

See FDA, Guide for Industry: Development and Use of Risk Minimization Action Plans (2005), http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005–4136b1_03_Risk%20Minimization%20Action%20Plans.pdf .

See FDA, Ctr. for Drug Eval. & Res., Risk Evaluation and Mitigation Strategy Assessments: Social Science Methodologies to Assess Goals Related to Knowledge (2012).

Dima M. Qato & Caleb Alexander, Improving the Food and Drug Administration's Mandate to Ensure Postmarketing Drug Safety, 306 J.A.M.A. 1595, 1595 (2011).

Pub. L. No. 110–85, § 901–21, 121 Stat. at 922–62.

FDA, FDAAA Implementation—Highlights Two Years After Enactment (Oct. 2, 2009), http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/ucm184271.htm.

Pub. L. No. 110–85, § 901, 121 Stat. 922; see also Laura B. Faden & Christopher-Paul Milne, Pharmacovigilance Activities in the United States, European Union and Japan: Harmonic Convergence or Convergent Evolution?, 63 Food & Drug L.J. 683, 687 (2008).

Pub. L. No. 110–85, § 905(c), 121 Stat. 949.

FDA, The Sentinel Initiative: A National Strategy for Monitoring Medical Product Safety (2008), http://www.fda.gov/Safety/FDAsSentinelInitiative/ucm089474.htm; Melissa Robb, FDA's Mini-Sentinel Exceeds 100 Million Lives and Counting: A Major Milestone in Developing a Nationwide Rapid-Response Electronic Medical Product Safety Surveillance Program (June 29, 2012), http://blogs.fda.gov/fdavoice/index.php/2012/06/fdas-mini-sentinel-exceeds-100-million-lives-and-counting-a-major-milestone-in-developing-a-nationwide-rapid-response-electronic-medical-product-safety-surveillance-program/.

Pub. L. No. 110–85, § 222, 121 Stat. 853.

Pub. L. No. 110–85, § 801, 121 Stat. 904.

Id.

Qato & Alexander, supra note 74, at 1595.

Id.

Id.

Id.

Id.(emphasis added).

Id. at 1595–96.

Id. at 1596.

Cameron Rhudy, How Congress May Have Failed Consumers with the Food and Drug Administration Amendments Act of 2007, 27 Biotechnology L. Rep. 99, 105 (2008).

Id.

Id.

Psaty & Burke, supra note 33, at 1755.

Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110–85, § 602, 121 Stat. 823, 898 (2007).

Rhudy, supra note 90, at 106.

Leape, supra note 49, at 1635.

Id.

Richard Platt, FDA's Mini-Sentinel Program to Evaluate the Safety of Marketed Medical Products: Progress and Direction, Harvard Pilgrim Health Care Insitute Presentation, 40 (2012), available at http://www.mini-sentinel.org/work_products/Publications/Mini-Sentinel_Presentation_Brookings-Annual-Sentinel-Public-Meeting_January2012.pdf.

Id. at 56.

Id.

Rhudy, supra note 90, at 107.

Id.

Food and Drug Administration Safety and Innovation Act, Pub. L. No. 112–144, § 905, 126 Stat. 993, 1092 (2012).

Jill Wechsler, Fleshing Out FDASIA, Pharmaceutical Executive, Aug. 1, 2012, available at http://www.pharmexec.com/pharmexec/Washington+Report/Fleshing-Out-FDASIA/ArticleStandard/Article/detail/784898.

See Michael Hay, Regulatory Watch: FDA PDUFA Goals Missed, Nature Rev., Jan. 2009, at 1, 1.

Timothy R. Franson, Has the FDA Amendments Act of 2007 Impaired Drug Development?, 89 Clin. Pharmacology & Therapeutics 169, 170 (2011).

Id. at 170–71.

Strom, supra note 12, at 2072–73.

Tomas J. Philipson & Eric Sun, Is the Food and Drug Administration Safe and Effective?, 22 J. Econ. Persp. 85, 93 (2008).

See, e.g., Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011), in which the Supreme Court ruled that a plaintiff cannot recover under state tort law for a generic drug maker's failure to warn of adverse events. The Court reasoned, under the doctrine of federal preemption, that Pliva could not simultaneously comply with FDA regulations (which require generic makers to have identical package inserts as those provided by the brand-name drug maker) and the state tort law doctrine of failure to warn. In this particular case, the brand-name drug maker's labeling did not provide information on the adverse event suffered by the plaintiff.

Zielinski, supra note 53, at 873.