Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Public Citizen Accuses FDA of a Coverup Re Off-Label Reprints Distribution Guidance

Public Citizen Accuses FDA of a Coverup Re Off-Label Reprints Distribution Guidance | Pharmaguy's Insights Into Drug Industry News |

Public Citizen has told HHS secretary Sylvia Burwell that FDA should withdraw its recent draft guidance on Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products — Recommended Practices because it would allow pharmaceutical companies to tell physicians that marketed drugs could be less risky than FDA-approved labels say they are.

In an October 22 letter to Burwell, the group's founder and senior advisor, Sidney M. Wolfe wrote that  the guidance would allow pharmaceutical salespeople to “inform physicians of the purportedly lower risks by distributing peer-reviewed articles assessing a drug's risks and discussing with doctors the information about the ‘lower' risks, without the FDA reviewing the articles, analyzing the data, or approving distribution of that information.”

His letter also complained about FDA's decision to withhold over 1,700 public comments on the draft guidance, suggesting that it is trying to cover-up criticism of the proposal.

“Of the 1,781 comments submitted on the proposal, only one comment has been posted on the government agency's Web site in the 58 days since the comment period closed,” Wolfe wrote, adding that on 10/15 it requested under the Freedom of Information Act the release of the comments.

Pharma Guys insight:

Sidney Wolfe Cries Foul!

In a JAMA Internal Medicine viewpoint article pub- lished on August 15, 2014, Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Re- search Group, argues that the draft guidance “suggests that the agency has now tilted toward protecting industry's commercial speech and away from protecting patients from the risks of prescription drugs and biological products” and would “let the pharmaceutical industry essentially circumvent drug labeling rules and tell doctors that its products have fewer risks than those described in the FDA-approv- ed labeling.”

Does Wolfe have a case? 

For more about that, read More FDA Guidance on Distribution of Reprints

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Health Canada Issues Warning About Possible Cardiovascular Problems Associated with Testosterone Products - FDA Sits Idly By

Health Canada Issues Warning About Possible Cardiovascular Problems Associated with Testosterone Products - FDA Sits Idly By | Pharmaguy's Insights Into Drug Industry News |

Health Canada is advising patients and healthcare professionals of new safety information regarding testosterone hormone replacement products and a risk of serious and possibly life-threatening cardiovascular (heart and blood vessel) problems.

Testosterone hormone replacement products are used in men who are experiencing medical conditions because their body cannot make enough testosterone. In Canada, there are 12 testosterone replacement products, including brand-name products: Androderm, Andriol, Delatestryl, Androgel, Axiron, Depo-Testosterone, Testim, and their equivalent generics.

Health Canada has recently completed a safety review on testosterone replacement products. This review found a growing body of evidence (from published scientific literature and case reports received by Health Canada and foreign regulators) for serious and possible life-threatening heart and blood vessel problems such as heart attack, stroke, blood clot in the lungs or legs; and increased or irregular heart rate with the use of testosterone replacement products. 

Health Canada is working with manufacturers to update the Canadian product labels regarding this risk. The Department continues to collaborate with foreign regulators including the United States Food and Drug Administration and the European Medicines Agency regarding this safety concern. Health Canada will keep Canadians informed and take action, as appropriate, if any new safety information is identified.

Pharma Guys insight:

At the exact same time that Health Canada issued its warning, FDA denied a petition by Public Citizen’s Health Research Group calling for a black-box warning about these same risks. FDA said it needs “further exploration of a possible safety signal” before issuing any warning about the risks of heart attacks and strokes. 


Sidney M Wolfe, MD, Founder and Senior Advisor, Public Citizen’s Health Research Group, issued a statement claiming that FDA's inaction vs. Canada Health's action on this health risk is an indication that the agency needs "new, more public health-oriented leadership" (read the statement here).

BTW, Public Citizen has a pretty good track record of identifying drug risks years in advance of those drugs being withdrawn for the market due to the risks it identified. Read more about that & listen to Wolfe's comments in this post:

Sydney Wolfe's 7-Year Drug Rule/Itch

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