Everybody wants to feel special. The cruise industry understands this. Airline rewards programs know this. The waiter at your favorite French bistro knows this. Parenting blogs are all over this with numerical precision: Simple Ways to Make Your Child Feel Special! Sixteen Ways to Make Your Child Feel Special Every Day! Seven Ways to Make Your Child Feel Special! How to Make a Child Feel Valued: 13 Steps with Pictures!
Pharmaceutical companies are pretty convinced they are special. In fact, each company’s products are so special that they need special expedited approval from the FDA. All of these drugs are so special that they’re not really special anymore. A third of the drugs approved by the FDA last year qualified for one of five “Special Approval Programs,” including Fast Track, Priority Review, Accelerated Approval, Orphan Drug Act, and the 21st Century Cures Act (http://nyti.ms/1bkOeK4).
It turns out the FDA wants to feel special too. The United States FDA must be faster than any other FDA, smarter than any other FDA, prettier than any other FDA, and approve more drugs than any other FDA. Here’s the FDA white paper on expedited approval programs: (http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm439082.htm)
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“Over the past two decades, the time required for FDA review has decreased from years to months – and the Agency has become the acknowledged leader among the world’s regulatory agencies in both the number of new drugs approved each year and in the timeliness of review. Today it remains the world’s leader.”
“[The]FDA continues to lead the European Union and other advanced regulatory authorities in the introduction of novel new drugs…In the years 2011-2013, the number of novel drugs launched first in the U.S. approached an all- time high, with roughly 60% of novel drug introductions occurring in the U.S. first, providing earlier access for U.S. patients.”
In order to gain this competitive edge, the FDA has reduced the number of review cycles required for approval after the initial submission of a drug. In 1993 two-thirds of applications for new drugs were not approved after initial review. Now initial approvals are up to 70%. Is that because researchers are getting better at writing the submission paperwork? Maybe they changed the font or got spell check. Are the drugs submitted so much more completely awesome than they were in 1993? In 1993 we got Zosyn (piperacillin-tazobactam), one of the most widely-used intravenous antibiotics; Neurontin (gabapentin), a seizure drug that has proved widely useful for acute and chronic pain; and Lovenox (enoxaparin sodium), a blood thinner now used post-operatively for virtually every procedure in which blood clotting is a risk. This year we got things like Cresemba for the treatment of invasive aspergillosis and invasive mucormycosis (approved March 2015), and Kybella for the treatment of submental fat (approved April 2015).
“Streamlining the efficiency of the drug development process is in everyone’s interest. American patients are realizing the benefits of FDA’s success in drug reviews because, in most cases, they are the first in the world to receive life-saving treatments for cancer and other serious diseases.”
Thank heaven for the FDA! If it weren’t for them, I’d be dying right now from submental fat. To be fair, the world also got Sovaldi (sofosbuvir), the only known treatment for hepatitis C, in 2013. But in general, U.S. patients don’t seem to be reaping the benefits of earlier access to all these special drugs, despite how special the pharmaceutical industry and the FDA are. According to The Commonwealth Fund, in 2007 the United States ranked 27th and 26th out of 33 countries within its peer group of Organization for Economic Co-operation and Development (OECD) countries for life expectancy at birth for females and males, respectively (http://www.commonwealthfund.org/~/media/Files/Publications/Issue%20Brief/2011/Jul/1532_Squires_US_hlt_sys_comparison_12_nations_intl_brief_v2.pdf). According to an article by David Squires in the July 2011 issue of Issues in International Health Policy, the United States ranks lowest in health and highest in health spending by any measure you choose. So to what group of people is the FDA referring when it says that streamlining is “in everyone’s best interest”?
“A responsive regulatory review program has allowed the pharmaceutical industry to continue to flourish, which in turn has benefitted the overall U.S. economy. For more than a decade, pharmaceutical company research and development has remained steady and strong, both as adjusted by inflation and as a percentage of sales, even during the economic downturn. While two million manufacturing jobs were lost during that time, less than 15,000 pharmaceutical jobs were lost, and pharmaceutical sales continued to keep pace with pre-recession levels.
“Stock performance is another measure of the economic health of this industry. For many years, the stock performance of pharmaceuticals has outstripped other industry segments, indicating robust investor confidence in the industry’s ability to remain competitive and profitable. For example, from May 2012 to May 2014, the Standard & Poor’s 500 saw a remarkable 40% increase in value while pharmaceutical stocks performed at double that rate.”
Oh.
