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Pharmaguy's News & Views Picks A collection of abstracts and links to pharmaceutical industry news and opinions curated by Pharmaguy™, a highly regarded industry pundit.

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Old 4th December 2012, 09:14 AM
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Default Off-label Free Speech * Keep Hamburg, Ditch Sebelius * Generic Drug Cliff Looms

December 4, 2012

(Also see the Pharmaguy SM Pioneer Daily:

[Contents: Off-label is Free Speech Says Appeal Court * Keep Hamburg, Ditch Sebelius * Why Hide CT Data? * Generic Drug Cliff]

U.S. court voids drug rep's conviction, cites free speech

A divided federal appeals court on Monday threw out the conviction of a sales representative for promoting off-label use of a prescription drug, a ruling that could make it harder for the government to police how drugs are marketed and sold.

The 2nd U.S. Circuit Court of Appeals in New York found that the sales representative's free speech rights under the First Amendment had been violated.

"In the fields of medicine and public health, where information can save lives, it only furthers the public interest to ensure that decisions about the use of prescription drugs, including off-label usage, are intelligent and well-informed," Circuit Judge Denny Chin wrote for a 2-1 majority.

See the opinion attached.

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Read these related articles:

President Obama, Please Retain Commissioner Hamburg
FDA Matters: The Grossman FDA Report™

With President Obama’s re-election, many people are sitting back and assuming that the U.S. Food and Drug Administration (FDA) won’t change much. In FDA Matters’ view, it doesn’t need to: Commissioner Hamburg is doing a good job; the agency is moving forward to improve food, drug and device safety; more rational and predictable review processes are being implemented; and there are at least three relatively new laws that need ongoing attention.

Grossman hopes that Commissioner Hamburg wants to stay and that President Obama chooses to keep her. There are positive, agency-affirming reasons supporting this.

Click here to

Meanwhile, perhaps it should be U.S. Department of Health and Human Services Secretary Kathleen Sebelius who should go. Read this article:

Access to clinical trial data: privacy rights, property rights and phoney rights
Dr. David Healy

At the European Medicines’ Agency meeting held on November 22nd convened to look at the issue of Access to Clinical Trial Data, the pharmaceutical companies came armed with an approach signaled a few weeks earlier by GSK’s Andrew Witty (see Won’t get Fooled Again). The industry panelists came from Lilly and UCB along with a representative from EurorDis Francois Houyez.

Possibly for the record, industry quietly raised their commercial interest in data secrecy in a jaw dropping argument that slipped quickly out of focus. Companies want to keep the data secret so that if for instance their drug gets rejected in Europe, they will still be able to submit the dossier for approval in Canada or Australia or India or wherever. Individual companies also want secrecy so that if they have wasted a lot of money finding out something doesn’t work, other companies won’t be able to save money through their experience.

But this was a footnote to the main show.

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Read this related article:

Generic Drug Makers See a Drought Ahead
NY Times

They call it the patent cliff.

Brand-name drug makers have feared it for years. And now the makers of generic drugs fear it, too.

This year, more than 40 brand-name drugs — valued at $35 billion in annual sales — lost their patent protection, meaning that generic companies were permitted to make their own lower-priced versions of well-known drugs like Plavix, Lexapro and Seroquel — and share in the profits that had exclusively belonged to the brands.

Next year, the value of drugs scheduled to lose their patents and be sold as generics is expected to decline by more than half, to about $17 billion, according to an analysis by Crédit Agricole Securities.“The patent cliff is over,” said Kim Vukhac, an analyst for Crédit Agricole. “That’s great for large pharma, but that also means the opportunities theoretically have dried up for generics.”

In response, many generic drug makers are scrambling to redefine themselves…

Click here to

(Also see the Pharmaguy SM Pioneer Daily:
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Last edited by pharmaguy : 4th December 2012 at 09:16 AM.
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