Ethics/Regulatory

FDA’s postmarket oversight of expedited drugs found lacking

Monday, April 11, 2016

The FDA lacks reliable, readily accessible data on potential safety issues needed to meet postmarket safety responsibilities and to conduct systematic oversight of new drugs.
This was the conclusion of a recent report issued by the U.S. Government Accountability Office (GAO). The GOA found that the FDA’s Center for Drug Evaluation and Research’s (CDER) internal data evaluations have problems with completeness and accuracy. These problems prevent the timely publication of legally required postmarket studies and reports on tracked safety issues—potential safety concerns the FDA determined to be significant, and which the FDA monitors using an internal database.

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Watchdog group files amendment to FDA Citizen Petition

Wednesday, March 30, 2016

With deaths in clinical drug trials every month since December 2015, Center for Responsible Science (CRS) has updated its July 2015 citizen petition. The petition urges the FDA to update 29 regulations to allow the preclinical test method most predictive of human response is used during drug testing. Current regulations mandate the use of animal models, despite great progress in more human relevant tests.

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Illinois psychiatrist sentenced for accepting pharma kickbacks

Monday, March 28, 2016

An Illinois-based psychiatrist, Michael J. Reinstein, M.D., has been sentenced to nine months in federal prison. In total, Reinstein took nearly $600,000 in consulting fees, vacation trips and other kickbacks in return for prescribing various forms of the antipsychotic drug clozapine to mentally ill patients in Chicago-area nursing homes and hospitals. At one point, Reinstein was the largest prescriber of the drug to Medicare recipients in the U.S.

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FDA releases enhanced warnings for immediate-release opioid pain medications

Wednesday, March 23, 2016

In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the FDA has announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications. Among the changes, the FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death. These actions are among a number of steps the agency recently outlined in a plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.

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Common Rule changes are first in 25-year history of human research protection

Saturday, March 19, 2016

The war in Iraq, officially called Operation Desert Storm, began under President George H. W. Bush. First-class postage increased from 25 cents to 29 cents. Silence of the Lambs was released in movie theatres. The Dow Jones Industrial Average closed at 3000 for the first time in its history. Mikael Gorbachev resigned as president of the Union of Soviet Socialist Republics and member states declared their independence. Clinical trials of statin drugs for treating high-cholesterol were being studied with mixed results. Looking back, research professionals undoubtedly would say that these major events occurred a long time ago.

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