EMA Documents Are ‘Secret No Longer’

from Pharmalot by Ed Silverman

 

Two years after the European Medicines Agency adopted a new policy that is designed to provide greater access to clinical trial data, a pair of researchers put the regulator to the test and found more than 1.6 million pages of documents have been released, according to a research letter published in the Archives of Internal Medicine (see here).

As a result, the researchers wrote the EMA policy toward access to documents is “secret no longer,” an about face after European Ombudsman chastised the regulator more than once for withholding trial data (see this). And their declaration comes not long before another milestone: in January 2014, the EMA will publish clinical trial data for the medications that are being considered for approval.
“If the EMA fulfills its promises, a new era of clinical trial data as a public good will begin. Data held by the agency will be available regardless of whether a trial is sponsored by industry, a medical research agency or a foundation, or initiated by investigators,” wrote Robert Steinbrook of the Yale School of Medicine in an accompanying commentary.

He adds a caveat, however. That’s because there are two aspects to the release of data. Currently, information the EMA already has requires a specific request, and then the EMA decides what will be release based on its policies. As for publishing trial data, which is to take place as of January 2014, the EMA will spend the next several months sorting out the particulars.

http://www.pharmalot.com/2012/12/ema-documents-are-secret-no-longer/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+Pharmalot+%28Pharmalot%29

 

Columnist Discusses Impact Of Election On FDA.

In Pharmalot (11/6), columnist Ed Silverman discusses how the outcome of the upcoming election will impact the FDA. Steve Grossman of the Alliance For A Stronger FDA non-profit, says that the FDA is not part of the election campaign dialogue. Grossman says this is a good thing, since "any intelligent discussion requires a long-term perspective and a mastery of detail and nuance, both of which are in short supply during sound bite-oriented politicking." However, he notes that the FDA will ultimately be affected by the election. Silverman asserts that the notion that the FDA "would largely continue on its current path with an Obama re-election is not hard to imagine. ... With Romney in the White House, however, the agency is likely to look and feel quite differently – and have a commish who is willing to 'swing the pendulum' away from an emphasis on safety and take any number of steps to speed approvals, regardless of budget cuts."

 

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What Will The FDA Look Like After The Election? from Pharmalot's Ed Silverman

from Pharmalot by Ed Silverman

Four more years or a few more weeks? Those are the choices in the upcoming election, but how might this affect the FDA? Apart from an occasional reference, the agency is not part of the campaign dialogue, notes Steve Grossman of the Alliance For A Stronger FDA non profit. And in his view, this is a good thing, since “any intelligent discussion requires a long-term perspective and a mastery of detail and nuance, both of which are in short supply during sound bite-oriented politicking. But of course, the FDA will be affected, one way or the other.

“First, is the potential for 8.2 percent federal budget cuts in January. Sequester, as the process is known, will leave FDA with about $320 million less to spend in Fiscal Year 13 than it did in Fiscal Year 12. This includes cuts to taxpayer-funded FDA appropriations, about a $2.5 billion base, and user fee revenue, nearly a $1.4 billion base). If cuts were applied entirely to FDA personnel, the agency would have to cut or furlough about 1,000 people,” he writes on his FDA Matters blog.

Continue here:  What Will The FDA Look Like After The Election?

What Expiration? Your Drugs May Last A Long Time - from Pharmalot

What Expiration? Your Drugs May Last A Long Time

from Pharmalot by Ed Silverman

Next time you decide to toss that prescription medicine because it appears to have expired, you may want to think twice. Why? A new analysis indicates that some prescription drugs retain their potency long after the expiration date, and the finding also suggests that the healthcare system could save untold oodles of money if expiration dates were sufficiently extended.
To wit, a team of researchers analyzed 14 different medications and found that 12, or 86 percent, tested at concentrations that were at least 90 percent of the amount on the labeling. Three actually had concentrations that exceeded the labeling; just two medications had less than 90 percent of the labeled concentration, according to a research letter published in the Archives of Internal Medicine (read here).

Collaborative Partnerships in Drug Development: An Executive Roundtable, DIA2012 June 26, 2012

48th Annual Meeting
June 24-28, 2012
Philadelphia, PA
Pennsylvania Convention Center

Collaborative Partnerships in Drug Development: A CRO CEO Roundtable Discussion

Tuesday, June 26, 2012
1:30–3:30 pm

Hear from top executives as they share their vision for the future of pharmaceutical development.

• What will it look like in five years, and how do we get there?

• What trends do we see?

• Have we seen the end of risk- and equity-sharing models in partnering?

• What are the pressures of private versus public ownership?

Moderator
Ed Silverman
Editor, Pharmalot
UBM, US

Paula Brown Stafford
President, Clinical
Development,
Quintiles, US

Jeffrey P. McMullen
President and CEO,
PharmaNet/i3, an inVentiv
Health Company, US

Douglas J. Peddicord, PhDExecutive Director,
Association of Clinical
Research Organizations, US

Josef von Rickenbach, MBA
Chairman and CEO,
PAREXEL International, US

William J. Sharbaugh, MA, MScCOO, PPD, Inc., US

John WatsonChief Commercial Officer, Corporate Senior Vice President
and President of Strategic Partnering,
Covance