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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The Valley vs. the FDA: Kleiner's Beth Seidenberg on Getting Along With the Agency Tech Loves to Hate

The Valley vs. the FDA: Kleiner's Beth Seidenberg on Getting Along With the Agency Tech Loves to Hate | Pharmaguy's Insights Into Drug Industry News | Scoop.it
She says the FDA's "breakthrough therapy" designation has accelerated approvals, but more reform is required.


While health is suddenly a hot topic in the region, a handful of venture capitalists have said they simply won’t invest in companies that require FDA approval — opting for the relative safety (or more obvious exits) of health apps and infrastructure plays over drugs and diagnostics. Others are looking for end runs around the system altogether.


In large part it’s a cultural clash. The ask-forgiveness-not-permission ethos of an Uber or Airbnb, which counts on consumer sentiment to swing policy, doesn’t play with the FDA. You’re not allowed to move fast and break things when it comes to people’s health. And the agency doesn’t take kindly to companies that violate its rules while ignoring repeated requests for information.


But some in Silicon Valley, particularly those who have no choice but to work with the FDA, are striving to locate what is ultimately some obvious middle ground: Yes, the FDA is slow, underfunded and understaffed. But beyond the invisible hand fringes, few are eager for a return to the days when the free market decided what was medicine and what was snake oil (or worse).


I caught Dr. Beth Seidenberg, a partner in the life sciences group at Kleiner Perkins Caufield & Byers and a physician who trained at Johns Hopkins University, sounding utterly constructive on the issue during a conference earlier this summer.


Seidenberg is the former chairperson and co-founder of the National Venture Capital Association’s Medical Innovation and Competitiveness Coalition, created in 2010 specifically to push for FDA reform. Before joining Kleiner, she was the chief medical officer at Amgen and a senior executive in research and development at Bristol-Myers Squibb.

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But have U.S. patients paid the price? Recalls of pharmaceutical products have surged in recent years, and 2014 is already shaping up to be the biggest year for serious drug recalls in the last decade, according to data made publicly available by the US Food and Drug Administration (FDA) late last month.

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Number of Drug Recalls Surges - Especially Ones with Serious AEs!

Number of Drug Recalls Surges - Especially Ones with Serious AEs! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Recalls of pharmaceutical products have surged in recent years, and 2014 is already shaping up to be the biggest year for serious drug recalls in the last decade, according to data made publicly available by the US Food and Drug Administration (FDA) late last month.


Pharmaceutical companies occasionally need to recall—that is to say, remove—products from the market. While the reasons for product recalls vary, they are commonly related to packaging defects, contamination of a product, improper testing of a product, or inherent safety problems which could lead a product to harm a patient.


Those recalls are classified according to a three-tier system administered by FDA:


  • Class I Recall - a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
  • Class II Recall - a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
  • Class III Recall - a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.


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Meanwhile, FDA's new off-label reprint distribution guidance states: "FDA does not intend to object to the distribution of new risk information that rebuts, mitigates, or refines risk information in the approved labeling, and is distributed by a firm in the form of a reprint or digital copy of a published study." For more on that, read 

FDA's "Off-Label Risk Reduction" Approach to Reprint Distribution is "Misguided," Says Sidney Wolfe

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