FDA

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Not just in the USA


Tweeted by @AllenFrancesMD

Disastrous EU decision- Pharma reg shifted from Health & Consumers to Enterprise & Industry
english.prescrire.org/en/79/207/4630...
Guess why

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"Mr Juncker, medicines are not just a commodity... (September 2014)"
http://english.prescrire.org/en/79/207/46302/3754/3303/SubReportDetails.aspx

In 2010, the EMA announced a proactive policy on transparency and public access to the data on which the Agency bases recommendations that directly affect the health of European citizens. This policy was in line with an inexorable international trend towards greater transparency and with what MEPs and the European Council wanted to achieve as part of the new regulations governing clinical trials. To the astonishment of observers and of activists who had been deeply involved in this positive development, the EMA made a spectacular retreat in recent months, coinciding with the arrival of the new head of its legal service (whose background was in the pharmaceutical industry).

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"Warning: clinical trials funded by drug companies may appear more truthful than they actually are"
http://ethicalnag.org/2009/11/13/gapabentin-trials/

Well, here's a shocker: apparently, there appears to be a difference between internal drug company documents about the research trials that they fund, and the articles reporting that research that end up in medical journals. The New England Journal of Medicine calls this 'selective outcome reporting', but for the sake of clarity, let's just call it 'lying'.

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Tweeted by @CUsafepatient

"Put safety at forefront for patients"
http://www.philly.com/philly/opinion/inquirer/20140926_Put_safety_at_forefront_for_patients.html

A major part of the problem is that the FDA itself is a split agency. In the food and drug arena, if a product is shown to cause a deadly illness in one in 350 to 500 people, it is pulled off the market. But the FDA's Center for Devices and Radiological Health (CDRH) is a different story.

The primary mission of the CDRH is to get "life-saving" technologies to the marketplace efficiently. Patient safety is secondary.

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Tweeted by @AllenFrancesMD

"The Havoc of the Unrestrained Drug Industry"
http://dissidentvoice.org/2014/09/the-havoc-of-the-unrestrained-drug-industry/

Dr. Angell charges that the industry is "primarily a marketing machine to sell drugs of dubious benefits, using its wealth and power to co-opt every institution that might stand in its way, including the U.S. Congress, the Food and Drug Administration, academic medical centers and the medical profession itself."

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Tweeted by @TomBurtonWSJ

"Lack of Publicly Available Scientific Evidence on the Safety and Effectiveness of Implanted Medical Devices"
http://archinte.jamanetwork.com/article.aspx?articleid=1910556

Conclusions and Relevance  Despite the legal requirement that scientific evidence of substantial equivalence be publicly available for medical devices cleared by the FDA through the 501(k) process, such information is lacking for most implanted medical devices cleared between 2008 and 2012, as well as for their predicates.

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Tweeted by @rvaughnmd

"FDA undermines painkillers fight: Our view"
http://www.usatoday.com/story/opinion/2014/09/29/fda-painkillers-hydrocodone-zohydro-overdose-editorials-debates/16455569/

The FDA's mission is determining whether drugs are effective and safe before approval. In Zohydro's case, the FDA flouted the recommendation of its own expert panel, which voted 11-2 against approval.

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Tweeted by @TomBurtonWSJ

"FDA Cracks Down on Sellers Touting Ebola Treatments
Agency's Move Is Part of an Effort to Stop False Claims Spreading Quickly on the Internet"
http://online.wsj.com/news/article_email/fda-cracks-down-on-sellers-touting-ebola-treatments-1412304777-lMyvQjAxMTI0NzA1MzMwNTMxWj

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Tweeted by @foodanddruglaw

"Public Health Groups Ask Congress For More FSMA Funding"
http://www.foodsafetynews.com/2014/10/public-health-groups-want-to-see-more-fsma-funding/#.VDXkvX-9KSO

"FDA estimates that it needs an additional $300 million over the next two to three years to fully implement FSMA," wrote the organizations, which include the Pew Charitable Trusts, the American Public Health Association, the American Academy of Pediatrics and the Infectious Diseases Society of America.

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"EU agency adopts plan to cut clinical trial secrecy"
http://www.reuters.com/article/2014/10/02/us-europe-medicine-secrecy-idUSKCN0HR28620141002

Europe's medicines regulator has endorsed a scheme to publish detailed clinical reports underpinning new drug approvals from next year, though campaigners for full transparency said they were concerned some data would still be missing.

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Tweeted by @foodanddruglaw

"Why Big Tobacco keeps demolishing the FDA in federal court"
http://tinyurl.com/osqyucy

the same federal judge, Richard J. Leon of the U.S. District Court in Washington, D.C. Leon's rulings have reflected concern about government overreach, and a tone of deep skepticism about the FDA's legal positions "Please! This conclusion defies common sense," he wrote, dismissing one of the agency's arguments.

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"Save The Children From The FDA"
http://www.forbes.com/sites/johngoodman/2014/10/07/save-the-children-from-the-fda/

Whenever the FDA gets involved, the cost of approval for any new invention or technology will be huge. The time it takes to get approval will be measured not in years but in decades. Hundreds of thousands of innovations that could have helped you and me will never come to market.

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Tweeted by @skepticonn

"This Harvard researcher wants you to know that your supplements can kill you"
http://www.vox.com/2014/10/8/6945793/ingredient-label-vitamin-supplement-health-bath-salts

"It took people getting sickened by it — having bleeds in their heads, dropping dead running marathons, that pathologists realized were due to DMAA — that finally moved the Food and Drug Administration to get DMAA off the market. That was seven years after it was introduced."

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Tweeted by @RAPSorg

"FDA Changes Policy Hours Before Approvals, Giving Companies Gift Potentially Worth Billions"
http://www.raps.org/Regulatory-Focus/News/2014/10/13/20549/FDA-Changes-Policy-Hours-Before-Approvals-Giving-Companies-Gift-Potentially-Worth-Billions/?utm_source=social&utm_medium=post&utm_campaign=RFnews

"As a result, an application for a fixed-combination submitted under section 505(b) of the FD&C Act will be eligible for 5-year NCE exclusivity if it contains a drug substance, no active moiety of which has been approved in any other application under section 505(b).30," FDA explained. "For example, a fixed-combination drug product that contains a drug substance with a single, new active moiety would be eligible for 5-year NCE exclusivity, even if the fixed-combination also contains a drug substance with a previously approved active moiety."

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Tweeted by @RAPSorg

"It's Not Just You: FDA Regulatory Requirements Really Are Increasing"
http://www.raps.org/Regulatory-Focus/News/2014/10/30/20656/Its-Not-Just-You-FDA-Regulatory-Requirements-Really-Are-Increasing/?utm_source=social&utm_medium=post&utm_campaign=RFnews

According to data made available by George Mason University's Mercatus Center and analyzed by Regulatory Focus, the number of regulatory requirements imposed by the US Food and Drug Administration (FDA) increased by 15% between the years 2000 and 2012.

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Tweeted by @baylenlinnekin

"The Feds 'Modernize' Food Safety Without Making Food Safer"
http://reason.com/archives/2014/11/01/fdas-fsma-modernizes-food-safety-without/singlepage

A few facets of the law actually make sense. Giving the FDA mandatory recall authority, as the law did, is an important tool for forcing foods that have been found to be a definitive hazard off the market.

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Tweeted by @RAPSorg

"Is FDA Listening Enough to Patients? Agency Wants Feedback"
http://www.raps.org/Regulatory-Focus/News/2014/11/03/20669/Is-FDA-Listening-Enough-to-Patients-Agency-Wants-Feedback/?utm_source=social&utm_medium=post&utm_campaign=RFnews

When Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law in 2012, its patient-centered provisions were among the biggest changes set to impact the culture of the US Food and Drug Administration (FDA). Now, two years later and with major planning already underway regarding the future of FDA's patient-centered activities, agency regulators are reaching out to the public to ask what more they can do to improve their efforts.

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Tweeted by @foodanddruglaw

"21 Disgusting Things That Are Legally Allowed In Your Food"
http://www.buzzfeed.com/carolynkylstra/disgusting-things-that-are-legally-allowed-in-your-food