Regulations, economics hindering adoption of personalized medicine

Thompson, Cheryl A.
March 2011
American Journal of Health-System Pharmacy;3/1/2011, Vol. 68 Issue 5, p372
Academic Journal
The article discusses the regulations and economics of the Medical Device Amendments of 1976, which pose a regulatory roadblock to the adoption of personalized medicine and diagnostics. It highlights that Section 510(k) of the Federal Food, Drug, and Cosmetic Act through which lower-risk medical devices enter the market. The article also discusses that the payer world prefers demonstrable outcomes and lower costs from coverage of a diagnostic test.


Related Articles

  • No Strings Attached. Peters, Rita C. // Drug Discovery & Development;May2012, Vol. 15 Issue 5, p4 

    The author discusses the implications of the reauthorization of the Prescription Drug User Fee Act (PDUFA) in the U.S. She explains that the legislation must be renewed before its expiration date on September 30, 2012 because it may compromise the drug review process and may force the Food and...

  • New drug and biological product approvals, 2010. Traynor, Kate // American Journal of Health-System Pharmacy;2/1/2011, Vol. 68 Issue 3, p186 

    The article presents the drugs which received the marketing approval from the U.S. Food & Drug Administration (FDA). It includes the Tocilizumab or Actemra which is used for treating moderate to severe rheumatoid arthritis, the Pradaxa oral thrombin inhibitor, and the tesamorelin or Egrifta for...

  • 2010 Pharmaceutical Approvals.  // American Journal of Health-System Pharmacy;2/1/2011, Vol. 68 Issue 3, p188 

    The article presents the 2010 approved drugs in the U.S. It includes the Alcaftadine ophthalmic solution treatment for allergic conjunctivitis, the Carglumic acid tablets use for treating acute hyperammonemia caused by the deficiency of N-acetylglutamate synthase (NAGS), and Dabigatran etexilate...

  • The Food and Drug Administration Amendments Act and Postmarketing Commitments. Fain, Kevin; Daubresse, Matthew; Alexander, G. Caleb // JAMA: Journal of the American Medical Association;7/10/2013, Vol. 310 Issue 2, p202 

    The article focuses on a study which examined the changes associated with post-marketing studies that are required for a prescription drug's approval and adherence by the U.S. Food and Drug Administration (FDA) as per the Food and Drug Administration Amendments Act (FDAAA) of 2007. It further...

  • Move to allow purchase of Canadian drugs rejected.  // Modern Healthcare;10/24/2011, Vol. 41 Issue 43, p4 

    This article reports on the U.S. Senate's disapproval of an amendment to the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill.

  • Duel over discounts: Pharma, providers at odds over 'orphan drugs' Daly, Rich // Modern Healthcare;1/23/2012, Vol. 42 Issue 4, p30 

    The article reports on an effort by U.S. hospitals to push for greater discounts on orphan drugs while the pharmaceutical industry intends to boost their profits from these drugs. Factors contributing to the financial promise of orphan drugs include longer exclusivity, an expedited regulatory,...

  • The Complexities of Litigating Generic Drug Exclusion Claims in the Antitrust Class Action Context. Royall, M. Sean; Lipton, Joshua // Antitrust Magazine;Spring2010, Vol. 24 Issue 2, p22 

    The article focuses on the complexities involved in litigating generic drug exclusion claims made by the branded pharmaceutical manufacturers under the U.S. antitrust law. It discusses the Hatch-Waxman Act which permits a generic manufacturer to file an Abbreviated New Drug Application, to be...

  • FDA suggests new user-fee programs for drugmakers.  // Modern Healthcare;1/16/2012, Vol. 42 Issue 3, p4 

    The article reports on the proposals sent by the U.S. Food and Drug Administration (FDA) to the U.S. Congress concerning the two user-free schemes for drug manufacturers that would help pay for faster evaluations of their generic and biosimilar drugs applications.

  • FDA Designations for Therapeutics and Their Impact on Drug Development and Regulatory Review Outcomes. Kesselheim, AS; Darrow, JJ // Clinical Pharmacology & Therapeutics;Jan2015, Vol. 97 Issue 1, p29 

    New prescription drugs receive approval from the US Food and Drug Administration (FDA) based on tests establishing safety and adequate and well-controlled trials demonstrating 'substantial evidence' of efficacy. However, a number of legislative and regulatory initiatives, the most recent being...

  • FDA Approvals & Regulations: Guide to Critical Analysis.  // Points of View: FDA Approvals & Regulations;3/1/2016, p4 

    The article offers a critical guide to the issue of U.S. Food and Drug Administration (FDA) approvals and regulations. The article discusses criteria in understanding the issue, such as distinguishing between fact and opinion and recognizing point and counterpoint arguments. Also presented are...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics