In 2002, the incoming Food and Drug Administration commissioner adopted a policy of expediting the process of approving new drugs for the post market phase consistent with the Prescription Drug User Fee Act (PDUFA) (Houlton, 2003). Yet non-government organizations who monitor drug safety have questioned the impartiality and objectivity of the FDA in adopting such a policy. It is deemed that private and profit-oriented pharmaceutical companies have increasingly influenced the drug approval process in order to expand their current hold on the market.
Industry influence on the FDA can be traced to several factors one of which is the increase in the former’s funding of the drug review and approval process of the latter. The PDUFA requires pharmaceutical companies applying for new drugs to pay fees to the FDA to avail of shortened review periods. However, while there is now ample funds for drug approval, funding for programs to ensure drug safety has remained inadequate which forced the agency to prioritize the monitoring of products with high potential for risks (Houlton, 2003).
In allowing commercial pharmaceutical companies to shoulder part of the agency’s funding, the FDA has effectively shifted its focus from patients or consumers to private companies as the primary beneficiaries of drug approval. This is a case of conflict of interest. This bias is evidenced in deregulated less stringent approval criteria or lower standards for approval which resulted in more drugs being approved but without a system of drug surveillance post market that is effectively in place (Wolf as cited in Frontline, 2003).
Moreover, the FDA’s attitude towards customer complaints has been of reluctance to address these issues and emphasis has been that the products are safe because it underwent agency review. There have been reports that high level FDA officials – because of pressure, often disregard the findings of the reviewers they employ when these negatively impact drug approval (Egertson, 2005). This was corroborated by a non-government organization survey of FDA reviewers themselves.
Although it is possible to determine safety issues in the pre market phase, the practices mentioned above allow drugs and other treatments to be approved even if their effectiveness have not yet been established. Moreover, new drugs which are proven to be neither significantly safer nor more effective than established drugs but are more expensive eventually find their way into the market. Thus, the safety of the public as users of drugs and other health-related products is severely compromised in favor of industry interests.
An example is that of Vioxx (rofecoxib) manufactured by Merck and Co. and approved in 2002 as treatment for arthritis wherein a review of the drug declaring that it did not meet safety standards was overturned by top level FDA officials (Egertson, 2005). As such, the drug was able to proceed to post marketing. Advisories were eventually issued against it a year later because compared to other drugs for the same illness Vioxx increased the rate of serious cardiovascular conditions.
This is while majority of the drugs that have been recalled recently were analgesics, anti-inflammatory and anti-allergenic anesthetics, classes of drugs with so many brands already available (Egertson, 2005). Other factors aggravate the issue such as the existence of pharmaceutical company lobbyists in Congress like the Pharmaceutical Research and Manufacturers of America (PhRMA). Through political pressure and campaign contributions, lobbyists work for legislations favorable for this sector of industry.
They have pushed for reforms in the FDA specifically in the area of further speeding up the drug approval process in order to save time and resources. There has also been relatively limited congressional oversight regarding the issue compared to the past decade (Wolfe as cited in Frontline, 2003). Congressional inquiries are important as they serve as a check and balance to the FDA process for drug approval. List of References Egertson, L. (2005). “Drug Approval System Questioned in US and Canada”. Canadian Medical Association Journal 172(3).
Retrieved 29 May 2009 from Academic Search Premier Database. Houlton, S. (2003). “Manufacturers Optimistic Ahead of FDA Review”. Chemical Week 19 February 2003. Retrieved 29 May 2009 from Academic Search Premier Database. Scott, A. (2006). “Drug Approval Rate Likely to Improve”. Chemical Week 168(1). Retrieved 29 May 2009 from Academic Search Premier Database. Frontline (2002). Interview: Sidney Wolfe M. D. Retrieved 29 May 2009 from file:///C:/Documents%20and%20Settings/User/Desktop/FDA%20and%20Pharmaceuticals/Interview%20with%20Sidney%20Wolfe%202. htm.