PharmExec Blog

New CDER “Super Office” to Promote Drug Quality

After almost two years of anticipation, Janet Woodcock, director of the Center for Drug Evaluation and Research, has administration approval for organizational changes to bolster programs and policies to ensure drug quality. The Department of Health and Human Services and the White House have finally signed off on her plan to establish a new CDER “super” Office of Pharmaceutical Quality (OPQ), a change originally proposed in the fall of 2012. The change aims to establish the “once voice for quality” that Woodcock has championed by providing “better alignment among all drug quality functions at CDER, including review, inspection and research,” Woodcock explained in an internal staff memo. Read More »

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Pulling Back the Curtains on Obamacare Rx Usage

It’s fall and the 2015 Obamacare Exchange Rx insurance offerings will be presented to patients on November 15th. But at this point, what insights do American Rx brand managers and marketers actually have on the results of the Obamacare Rx experience in 2014?

Up until now, very little publicly available information on what Obamacare Rx utilization has been available. We’ve known next to nothing about the demographics of patients who used the program, and most importantly, the costs associated with various Rx therapeutic groups were unclear. All of this changed this past week.

On October 7, 2014 the New York Times published a story detailing the first six months of Rx experience with the Obamacare exchanges as reported by two of Obamacare’s major public exchange pharmacy benefit managers: Express Scripts and Prime Therapeutics. Read More »

Posted in healthcare, Op-Ed | 1 Comment

Cancer Medicines: Setbacks and Stepping Stones

A report released on this week by the Pharmaceutical Research and Manufacturers of America (PhRMA), “Researching Cancer Medicines: Setbacks and Stepping Stones,” highlights the number of investigational cancer medicines that did not succeed in clinical trials and how these so-called “failures” are a crucial part of the drug development process. Read More »

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Unlocking the True Value of Big Data: A Pharm Exec Global Digest Special

In this special issue of Pharm Exec Global Digest: Unlocking the true value of Big Data; Data privacy
and the health sciences; In-silico modeling and real-word outcomes; and more…PEGD0914_thumb

Click here to access the issue.

Posted in Strategy | Leave a comment

Preparing for Reentry: A Physician’s Story

By Daniel Laury, M.D.

You would expect that, given a physician shortage, my goal of getting back into obstetrics would be supported and even welcomed.  The Association of American Medical Colleges expects that the US will have over 91,000 too few physicians by 2020.  I graduated medical school in 1988, completed an OBG residency in 1992 and went right into private practice.  By 2002, I stopped delivering babies, focusing on gynecology, women’s primary care, esthetics, teaching, writing and research.

It became increasingly clear that the private practice model has been disappearing over time. Our reimbursement is going down, our costs are up, we are underrepresented in negotiations, etc.  The AMA found that since 1983, physicians in private practice have decreased from 40.5% of the total to about 18.5% in 2012.  I was tired of the constant competition; in the US, the average number of OBs is one for every 13,021 persons. However, in my locale it was closer to 1 in 4,375. I was not looking forward to buying and getting trained on $50,000 of EMR.  The administrative burden of OSHA, CLIA, ACA, HIPAA and other acronyms was unsupportable.  Taking time off in private practice is also costly; income stops when I am not working but expenses continue including rent, staffing costs, malpractice premiums… Patients can be unhappy when you take time off, expecting that their private doctor is always available to them.

Mark Twain’s comment, “Twenty years from now you will be more disappointed by the things that you didn’t do than by the ones you did do” rang true for me.  I looked at my options, many that may be familiar to you, including administrative work, insurance opportunities, working for the military, writing full time, academics, giving talks and going into another field altogether. Ultimately, I decided that locums tenens work with be the best fit. I talked to various providers and overall, they seemed happier, more mobile and worked when they wanted to.   Read More »

Posted in Guest Blog, healthcare | Tagged , , | 1 Comment
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