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Medicine and Public Policy |

Enhancing Prescription Drug Innovation and Adoption

G. Caleb Alexander, MD, MS; Alec B. O'Connor, MD, MPH; and Randall S. Stafford, MD, PhD
[+] Article, Author, and Disclosure Information

From University of Chicago Hospitals, University of Chicago, and University of Illinois at Chicago School of Pharmacy, Chicago, Illinois; University of Rochester School of Medicine and Dentistry, Rochester, New York; and Stanford University School of Medicine, Stanford, California.

Acknowledgment: The authors thank Dr. Robert H. Dworkin, Professor of Anesthesiology, Neurology, Oncology, and Psychiatry at the University of Rochester School of Medicine and Dentistry, for his thoughtful comments on an earlier manuscript draft.

Grant Support: By grants K08 HS15699 and RO1 HS0189960 from the Agency for Healthcare Research and Quality (Dr. Alexander) and grant K24 HL086703 from the National Heart, Lung, and Blood Institute (Dr. Stafford).

Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M10-2998.

Requests for Single Reprints: G. Caleb Alexander, MD, MS, University of Chicago Medical Center, 5841 South Maryland Avenue, MC 2007, Chicago, IL 60637; e-mail, galexand@uchicago.edu.

Current Author Addresses: Dr. Alexander: University of Chicago Medical Center, 5841 South Maryland Avenue, MC 2007, Chicago, IL 60637.

Dr. O'Connor: Strong Memorial Hospital, 601 Elmwood Avenue, Box HMD/MED, Rochester, NY 14642.

Dr. Stafford: Stanford Prevention Research Center, Stanford University, 1000 Welch Road, Palo Alto, CA 94304-1825.

Author Contributions: Conception and design: G.C. Alexander, A.B. O'Connor, R.S. Stafford.

Analysis and interpretation of the data: R.S. Stafford.

Drafting of the article: G.C. Alexander, R.S. Stafford.

Critical revision of the article for important intellectual content: G.C. Alexander, A.B. O'Connor, R.S. Stafford.

Final approval of the article: G.C. Alexander, A.B. O'Connor, R.S. Stafford.

Provision of study materials or patients: R.S. Stafford.

Statistical expertise: R.S. Stafford.

Obtaining of funding: R.S. Stafford.

Administrative, technical, or logistic support: G.C. Alexander, R.S. Stafford.

Collection and assembly of data: R.S. Stafford.

Ann Intern Med. 2011;154(12):833-837. doi:10.7326/0003-4819-154-12-201106210-00012
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The adoption and use of a new drug would ideally be guided by its innovation and cost-effectiveness. However, information about the relative efficacy and safety of a drug is typically incomplete even well after market entry, and various other forces create a marketplace in which most new drugs are little better than their older counterparts. Five proposed mechanisms are considered for promoting innovation and reducing the use of therapies ultimately found to offer poor value or have unacceptable risks. These changes range from increasing the evidence required for U.S. Food and Drug Administration approval to modifying the structure of drug reimbursement. Despite the challenges of policy implementation, the United States has a long history of successfully improving the societal value and safe use of prescription medicines.





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