Navigation Links
How the US drug safety system should be changed

As Strom writes, "the net effect of [the current system] is that the public misunderstands drug safety, believing that a drug is safe at the time of marketing, while [adverse] events occurring as frequently as 1 in 1000 are predictably undetected."

In the May 3 issue of the Journal of the American Medical Association, Brian L. Strom, MD, MPH, Professor of Public Health and Preventive Medicine and Chair of the Department of Biostatistics and Epidemiology at the University of Pennsylvania School of Medicine, analyzes the limitations of the current system of drug-safety monitoring and proposes a solution that addresses overly aggressive early marketing practices; an absence of incentives to complete post-marketing safety studies; direct-to-consumer (DTC) advertising that can promote non-critical use of "blockbuster" drugs; the current trend toward delaying drug approval; and public misunderstanding about the safety of drugs.

Strom proposes an alternative approach with three elements: conditional approval, an empowered US Food and Drug Administration (FDA), and a complementary nongovernmental organization.

When a drug is initially approved, it should ideally enter a period of conditional approval, he says. In this period, marketing, especially DTC, would be restricted. Drug labels would need to be clearly marked that the drug's approval is conditional and has only been studied in a limited number of patients. Removal of label caveats would depend on the outcome of subsequent studies and their findings, depending on the numbers of individuals in the studies, and the risk and novelty of the drug, as well as addressing all premarketing safety questions.

"The current system is moving toward a delay in drug approval, still followed by optional postmarketing studies," notes Strom. "Instead, the proposed approach would be conditional approval followed by postmarketing studies required before the condition is removed."

Secondly, Strom ma intains that the FDA needs an increased ability to regulate drugs after marketing, so that it can require post-marketing studies and labeling changes as a rule, rather than those changes being subject to negotiation between the regulatory agency and industry. It also needs substantially more resources for the postmarketing study of drug safety.

Strom concludes by proposing that an independent, nongovernmental organization is needed for nonregulatory tasks that are not within the mission of the FDA. Since many of these tasks are academic in nature ?for example, performing postmortem examinations in the event of drug disasters or developing new pharmacoepidemiological methods ?he suggests that the Agency for Healthcare Research and Quality (AHRQ)-funded Centers for Education and Research in Therapeutics (CERTS) or the Institute of Medicine (IOM) might play a role.

"A key benefit of this proposed approach for the public would be that drug use immediately after marketing would be reduced to those who truly need the drug, in whom the risk-benefit balance in the face of uncertainty is more favorable," Strom says.


'"/>

Source:University of Pennsylvania School of Medicine


Related biology news :

1. Aloe vera coating may prolong freshness, safety of fruits and vegetables
2. Feds give researchers ok for safety test of adult stem cells in patients with heart disease
3. Flesh-eating bacteria escape bodys safety net
4. Magnetism and mimicry of nature hold hope for better medicine, environmental safety
5. Fake pesticides threaten food safety
6. Fox Chase Cancer Center scientists identify immune-system mutation
7. Open microfluidic and nanofluidic systems
8. Studies reveal methods viruses use to sidestep immune system
9. Alcohols effects on gene expression in the central nervous system
10. Jumping gene helps explain immune systems abilities
11. White blood cell waste disposal system plays critical regulatory role
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:5/16/2017)... --  Bridge Patient Portal , an enterprise patient ... Systems , an electronic medical record solutions developer ... a partnership to build an interface between the ... products, including Centricity Practice Solution (CPS), Centricity Business ... integrations will allow healthcare delivery networks using GE ...
(Date:4/17/2017)... NXT-ID, Inc. (NASDAQ: NXTD ) ("NXT-ID" ... its 2016 Annual Report on Form 10-K on Thursday April 13, ... ... the Investor Relations section of the Company,s website at http://www.nxt-id.com ... http://www.sec.gov . 2016 Year Highlights: ...
(Date:4/11/2017)... 11, 2017 No two people are ... the New York University Tandon School of Engineering ... found that partial similarities between prints are common ... mobile phones and other electronic devices can be ... vulnerability lies in the fact that fingerprint-based authentication ...
Breaking Biology News(10 mins):
(Date:10/11/2017)... ... October 11, 2017 , ... At its national board meeting ... I. Sheikh, the co-founder, CEO and chief research scientist of Minnesota-based Advanced Space ... membership in ARCS Alumni Hall of Fame . ASTER Labs is a ...
(Date:10/11/2017)... Alto, CA, USA (PRWEB) , ... October 11, 2017 , ... ... set to take place on 7th and 8th June 2018 in San Francisco, CA. ... policy influencers as well as several distinguished CEOs, board directors and government officials from ...
(Date:10/11/2017)... HILLS, Calif. , Oct. 11, 2017  SkylineDx today ... (ICR) and University of Leeds ... risk-stratify patients with multiple myeloma (MM), in a multi-centric Phase ... University of Leeds is the sponsor ... and ICR will perform the testing services to include high-risk ...
(Date:10/11/2017)... Bay, Florida (PRWEB) , ... October 11, 2017 ... ... and Drug Administration (FDA) has granted orphan drug designation to SBT-100, its novel ... (sdAb) for the treatment of osteosarcoma. SBT-100 is able to cross the cell ...
Breaking Biology Technology: