FDA to Place New Limits on Prescriptions of Narcotics
Many doctors may lose the opportunity to prescribe 24 popular narcotics as part of a new effort to reduce the deaths and injuries that result from these medicines' inappropriate use said federal drug officials.
A new control program will result in further restrictions on the prescribing, dispensing, and distribution of extended-release uploads like OxyContin, fentanyl patches, methadone tablets, and some morphine tablets.
These products are classified as Schedule II narcotics and already are restricted by the FDA and the DEA. However, the current restrictions are not meeting the goals that the FDA's new drug center wants to achieve.
They are talking about putting in place a program to try to ensure that physicians prescribing these products are properly trained in their safe use before they can actually prescribe these products. This is going to be a massive program.
http://www.nytimes.com/2009/02/10/health/policy/10fda.html?_r=1
Pfizer to List Payments to Doctors, Researchers
Pfizer reported it will begin next year to disclose most payments made to doctors and other U.S. healthcare professionals to comply with the spirit of recently proposed legislation and boost trust in its products and collaborations.
By early 2010, Pfizer aims to begin listing its payments for consulting, speaking engagements, and clinical trials on its Website (www.pfizer.com).
This will make Pfizer the first biopharmaceutical company to commit to reporting payments for conducting Phase I to Phase IV clinical trials, in addition to disclosing payments for speaking and consulting.
However, the new disclosure plan does not cover payments to some contributors to medical journal articles, such as technical medical writers who do not prescribe medicines and who are sometimes listed as authors of formal study findings.
Pfizer, in some cases, will compensate a technical writer to work under the direction of a clinical trial investigator and the technical writers' contributions will be publicly disclosed in the acknowledgments section of the article. This disclosure does not provide details about these specific payments.
Industry critics have complained that many important medical journal articles are written by "ghostwriters" who have not actually been involved in clinical trials, but nevertheless make strong conclusions about a drug's effectiveness and safety that can impress doctors and boost sales of the medicine.
Pfizer said medical journal articles written with the help of its hired technical writers do not constitute "ghostwriting" if assistance from the writer is noted in the acknowledgments section of the article.
http://www.reuters.com/article/rbssHealthcareNews/idUSN0953964720090210
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