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:2/2/2016)... YORK , Feb. 2, 2016 /PRNewswire/ ... facilities are primarily focused on medical screening ... measure point-of-care parameters. Wearable devices that facilitate ... user,s freedom of movement are being bolstered ... for human biomedical signal acquisition coupled with ...
(Date:2/2/2016)... --Technology Enhancements Accelerate Growth of X-ray Imaging This ... computed radiography markets in Thailand , ... (TIM). It provides an in-depth analysis of ... regional market drivers and restraints. The study offers revenue ... attractiveness, both for digital and computed radiography. Market participants ...
(Date:2/1/2016)... Canada , February 1, 2016 ... technological advancements to drive global touchfree intuitive gesture control ... --> Rising sales of consumer electronics coupled ... gesture control market size through ... consumer electronics coupled with new technological advancements to drive ...
Breaking Biology News(10 mins):
(Date:2/11/2016)... ... February 11, 2016 , ... Reichert Technologies, ... continues today to pursue the highest level of accuracy and quality with the ... Refractometer and the AR5 Refractometer. Accurate, reliable and tough enough for the ...
(Date:2/11/2016)... ... , ... Global Stem Cells Group, has announced ... new facility will provide advanced protocols and state-of-the-art techniques in cellular medicine, focusing ... The new GSCG clinic is headed by four prominent Ecuadorian physicians, including Pablo ...
(Date:2/10/2016)... 10, 2016 Early-career researchers from ... Peru , Uganda and Yemen ... health and nutrition   Indonesia , ... and Yemen are being honored for their ... are also celebrated for mentoring young women scientists who are pursuing careers ...
(Date:2/10/2016)... Feb. 10, 2016 NX Prenatal Inc., a ... NeXosome® technology for early warning of adverse pregnancy ... recent study by Dr. Thomas McElrath ... Maternal Fetal Medicine,s (SMFM) annual meeting held in ... , 2016.  The presentation reported initial positive top-line ...
Breaking Biology Technology: