Globally, many nations have been working to improve the regulatory guidelines for medicinal products. In the US, the 1962 Food, Drug and Cosmetic Act, gave the US food and Drug Administration (FDA) the power to control the pre-market and post-market products (FDA, 2005). The new FDA power also became the catalyst and makes the FDA a highly scrutinized and criticized government agency, especially when a medicinal product has serious adverse events post-product approval by the FDA. The overwhelming blames that goes to the FDA when such an unfortunate event happens, puts the organization in more cautious and conservative status, in the approval process for new drugs or products (Hamrell, & Dombey, 2012). Furthermore, the biggest bottle neck facing the FDA is the lack of manpower in overseeing new drug reviews and officiating efficient approval of safer new drugs.

In 1970’s, there is growing discontent in the FDA’s lag process for new drug approval, which prompted Sam Peltzman to conduct an economic study on the FDA. The main purpose of the study was to evaluate how the new drug approval lag may impact the US economy and most importantly, the public health care system (FDA, 2005). His conclusion was disturbing and provoking. In the study, Peltzman discovered that medicinal products are approved faster in Europe than in the US. Based on the study, he suggested that if the lag continues, the US pharmaceutical industries and the public health will be in a deleterious situation (FDA, 2005). The outcome of his report deepened the distaste of the FDA approval process and appealed to the demand for a complete overhaul of the agency’s approval process. This built up momentum for a change surged into the 80’s when the HIV/AIDS epidemic was on the rise. The epidemic empowered the HIV/AIDS awareness advocates/organizations that are in desperate need of therapy for the HIV/AIDS victims, in pressuring a change in the FDA’s drug approval process (FDA, 2005). This gave rise to the enactment of the 1992 prescription drug user’s fee act (PDUFA) (FDA, 2005). The basic purpose of the PDUFA was to help the FDA increase staffing and reviewing process on new drug applications. The PDUFA requires pharmaceutical companies filling for new drug application (NDA) or biologic license application (BLA) to pay the FDA $200,000 to $1,958,000 for an application and review process (Aptiv Solutions, 2013). The PDUFA do not guarantee the approval of any medicinal product, it only covers the FDA’s cost for the review process (Hennessy, & Strom, 2007). In addition, the PDUFAII and PDUFAIII application process minimizes medicinal product’s approval delay by allowing the FDA to standardize clinical trials across the nation (FDA, 2005). It has been determined by experts in the field that the PDUFA fees, significantly expedite the approval and review process from 2-3 years to only 12 months (Hamrell, & Dombey, 2012).

Although there are still deep concerns about PDUFA and conflict of interests. The introduction of the fee reduced the federal government’s 100% financially burden in the medicinal product’s approval process. Other valid concern is whether the FDA efficiently allocates the PDUFA fees given the increasing nature of product recalls (Hennessy, & Strom, 2007). The PDUFA or any regulatory law cannot resolve the lack of proper management thereof in the FDA. The administrative level in the organization is obligated with moral and ethical responsibility, to achieve and reach the goals of the Act.

It is also very important that the public need to understand and manage their expectations. When the PDUFA encourages and expedite faster approval of a new product, the process does not guarantee safer medicinal products. Rapid approval process may also mean that consumers are exposed to unnecessary risks.

As new pharmaceutical companies emerge and new drug applications pill up, the FDA is still faced with potential lag or backlogs in the approval process. The approval backlogs are inevitable with the current rate at which the industry is growing in respect to the FDA’s expansion. Based on the FDA’s 2010 fiscal year budget summary, it is apparent that the level of increase in new drug applications and clinical trials under the FDA’s purview has gone up drastically. With about 346 FDA inspectors, it is practically an impossible review task to catch up with thousands of clinical trials across the US and global sites without any error and backlogs (FDA, 2010). For the 2013 fiscal year, the number of full time FDA employees is 13,712 people (FDA,2012). About 4,763 people are employed under regulatory affairs (FDA.2013). There are more than 92,930 new investigational drug applications, and 28,594 other new submissions from 2011 (FDA. 2012). Basically, with the amount of people the FDA have for reviews, backlogs is inevitable and it is almost impossible to eschew.

George Santayana said, “Those who cannot remember the past are condemned to repeat it” (Waldenu, 2012). The global regulatory agencies must be proactive in securing drug safety rather than always reacting to safety events. These agencies will be better off if they actively anticipate problems and try to mitigate the issue before it gets worse. Regulatory agencies should monitor and audit clinical trial sites more often before the approval process is completed.

References

Aptiv Solutions. (2013). PDUFA V– Impact of the New Rules on NDA Filings Retrieved from http://www.aptivsolutions.com/blog/2013/06/pdufa-v-impact-of-the-new-rules-on-nda-filings/

FDA. (2009). The History of Drug Regulation in the United States. Retrieved from http://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the-CounterMedicines/ucm093550.pdf

FDA. (2010). How to Become a U.S. Food and Drug Inspector. Retrieved from http://www.fda.gov/AboutFDA/WhatWeDo/History/Overviews/ucm109718.htmhttp://www.fda.gov/AboutFDA/WhatWeDo/History/FOrgsHistory/CDER/default.htm .

FDA. (2012). Total submissions routed to drug review. Retrieved fromhttp://www.accessdata.fda.gov/FDATrack/track?program=cder&id=CDER-OPI-Total-     submissions-routed-to-drug-review.

FDA. (2010). How many people are employed by FDA and in what areas do they work? Retrieved from http://www.fda.gov/AboutFDA/Transparency/Basics/ucm213161.htm.

http://www.fda.gov/aboutfda/reportsmanualsforms/reports/budgetreports/ucm153154.htm

FDA. (2009). Milestones in U.S. Food and Drug Law History. Retrieved from http://www.fda.gov/AboutFDA/WhatWeDo/History/Milestones/default.htm.

FDA. (2005). Panel 1 – Presentations by FDA, Prescription Drug User Fee Act Public Meeting November 14, 2005. Retrieved from http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm126994.htm.

FDA. (2013).  Food and Drug Administration Distribution of Full-Time Equivalent (FTE) Employment Program Level.  Retrieved from http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/ BudgetReports/UCM301553.pdf.

Hamrell, M. & Dombey, S. ( 2012). The FDA and Drug Regulation. DVD.  Retrieved from http://sylvan.live.ecollege.com/ec/crs/default.learn?CourseID=6493792&Survey=1&47=10828390&ClientNodeID=984640&coursenav=1&bhcp=1.

Hennessy, S., & Strom, B. L. (2007). PDUFA reauthorization—Drug safety’s golden moment of opportunity? The New England Journal of Medicine, 356(17), 1703–1704. Retrieved from http://ezp.waldenulibrary.org/login?url=http://proquest.umi.com.ezp.waldenulibrary.org/pqdweb?did=1260820021&sid=1&Fmt=3&clientId=70192&RQT=309&VName=PQD.

Oreilli, Brian.(2007, July 17). An Investor’s Guide to the New PDUFA. Retrieved April 4, 2012 from http://www.fool.com/investing/high-growth/2007/07/17/an-investors-guide-to-the- new-pdufa.aspx