PharmExec Blog

Are You Aging Well? Ask Pfizer

I’ve just finished taking Pfizer’s #FOGO (Have A Fear of Getting Old?) test on I passed with flying colors. The results assured me that I would have a hell of a time aging during these advancing years and that the last lap of my life would be a breeze.

Why? I wonder. Was it because I answered that I preferred reading Jane Austen to “Everyone Poops,” or that I didn’t like pizza, or that I could run 2 miles without stopping? Hard to tell. The test was more silly than scientific. It was also inaccurate. I couldn’t be more concerned and, yes, afraid about growing old (since I am getting on, as they say). Basically I agree with Bette Davis when she famously said: “Getting old is not for sissies.” It’s daunting—your body goes, your mind goes. There is the trade-off of gaining some wisdom along the way…maybe. But basically it is a bitch.

#FOGO, a social media public relations campaign, is the brainchild of Pfizer, the world’s number one drug company. But make no mistake. It is not for promoting a drug. It is not even for exclusively alleviating the fear of aging (if that’s remotely possible). Its primary purpose is to make you feel good about Pfizer. Read More »

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More Finger Pointing Over Sunshine System Snafus

Further delays in implementing the Open Payments program for disclosing industry financial relationships with prescribers has ignited a blame-game over who is at fault. The Centers for Medicare and Medicaid Services (CMS) is citing inaccurate data from pharma and medical device companies for the latest problems involving erroneous payment attributions.

Manufacturers maintain they fully validate data filings and have to “attest” to its accuracy, and that the latest problems arise partly from constant changes by CMS in data formats and templates.

Everyone is eyeing contractor CGI Federal, which CMS engaged to build the submission portal for the complex data system, evidently before CGI’s debacle in launching the insurance exchange a year ago.

Physicians, meanwhile, are livid over the prospect that CMS will release inaccurate payment information, as the agency continues to insist on going live with Open Payments Sept. 30. The latest problems with Open Payment came to light when ProPublica reported on a doctor in Kentucky who examined his payment report and found funds credited to him that actually went to a physician in Florida with the same name. Health care professionals (HCPs) have the opportunity to pre-review their reports and file complaints, a process that has proven to be extremely cumbersome and time-consuming. Physicians have been pressing for CMS to delay the program another six months, but the agency is under intense pressure from Congress to launch on time. Read More »

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USP Analytical Research Award Winners 2014

An international group of three scientists are the recipients of United States Pharmacopeial Convention’s 2014–2015 Global Fellowship Awards, aimed at advancing research involving quality standards for medicines. The recipients’ research will involve analytical tools useful in researching the safety of biopharmaceutical drugs, the detection of substandard drugs in the developing world, and the quality of dry powder inhaler products.

Each of the following students has received a $30,000 USP Global Fellowship Award for the 2014–2015 academic year: Read More »

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Implementing the Generic Drug User Fee Act: Struggles and Successes

Two years into the Generic Drug User Fee Act (GDUFA) program, enacted in July 2012, FDA officials are striving to meet goals and timelines for speeding new generic drugs to market. Agency reviewers have made some progress in eliminating the huge backlog in abbreviated new drug applications (ANDAs) pending in the Office of Generic Drugs (OGD), but not as quickly as manufacturers had anticipated. New guidance from FDA aims to help manufacturers meet standards and to streamline oversight. But a continual rise in submissions to the agency makes it hard for reviewers to get ahead, especially in the wake of a surge of 600 ANDAs filed in June to beat new stability testing requirements. Read More »

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mHealth Set to Transform Clinical Trials

The health sciences industry received some important and encouraging news from the US Food and Drug Administration (FDA) in late June—an announcement that may, ultimately, help to transform the way data is collected in clinical trials and lead to safer studies and faster time to market.

The FDA issued new draft guidance that stated its intent to not actively regulate certain health IT devices. It also signaled that IT products that straddle the line between IT and devices would also be exempt. This is good news for mHealth solution developers and health sciences organizations engaged in clinical development, clearing the way for faster development and more confident adoption.

In this Applied Clinical Trials article, Oracle Health Science’s Mukhtar Ahmed outlines mHealth technologies’ potential to transform clinical development programs, including clinical trials.

Read more.

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