To Defend the People

By: Davidta Brown, Senior Staff Editor

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As the world’s largest market for pharmaceuticals, the United States receives many medications manufactured abroad.¹ Patients, physicians, and pharmacists defer the responsibility of ensuring the quality of these imported drugs to the FDA, but it only takes one report of deceit in the pharmaceutical industry for this trust to be shaken. In 2005, an employee of Ranbaxy Laboratories Ltd., a major manufacturer of generic medications sold internationally and in the U.S., reported multiple cases of fraudulent or nonexistent drug evaluation data to his superiors.² The test results required for generic drugs to receive approval had been altered, while evidence of the actual tests was lacking. After an alarming lack of response from corporate directors, the employee turned to the FDA, initiating an investigation that spanned several years and culminated in the prohibition of drug imports from certain Ranbaxy facilities, as well as the collection of $500 million in fines.³

The free market ordinarily punishes those who would cheat the general public, without any regulatory interference – when a company produces poor quality merchandise, consumers choose to spend their money elsewhere. Unfortunately, consumers in the market for pharmaceuticals do not have the same freedom of choice. The consumer sacrifices the ability to freely make decisions in the market, and leaves the judgment between goods to medical professionals. As a result, when news of fraudulence like that exemplified by Ranbaxy is brought to light, patients can be expected to feel that their best interests are not prioritized. They may anxiously search their medicine cabinets for “bad drugs,” or stop taking their medications entirely. The fear generated by behavior like Ranbaxy’s is easily as harmful as the substandard medications themselves, and the remedy to that fear is for the patient and consumer to feel that they have a genuine ally in the FDA.

It is beyond the scope of the FDA’s authority to anticipate corporate greed and prevent pharmaceutical manufacturers from taking shortcuts, but interested parties can still wonder how patients may protect themselves from deceitful activity. The first question to ask is whether the ability to submit falsified documents to the FDA and receive approval to market generic drugs indicates a deficiency in the regulatory powers of the FDA, or in the generic drug approval process. This question ought to be answered with a negative. Unlike approval applications for completely new drugs, generics are approved through an Abbreviated New Drug Application, which requires data proving bioequivalence to the original drug rather than clinical data on safety and efficacy.⁴ The abbreviated drug approval protocol that is meant to encourage competition necessarily leaves manufacturers to an honor system. However, this should not imply that more stringent testing should be required of generic drug manufacturers. If generic drugs were put up to the level of testing and scrutiny that patented brand name drugs receive, very few manufacturers would enter the generic market, and all patients would suffer from the resulting elevation of drug costs. The solution to the problem of protecting the public from fraud must be sought elsewhere.

If the FDA appears to take cheating seriously, the patient can trust that FDA approval signifies reliably high standards. Actions such as prohibiting the manufacture of FDA approved drugs at specific plants, which the FDA carried out against Ranbaxy as recently as last September, remind patients and healthcare providers that the established regulatory body is active and working, especially when reports of such actions are well publicized.⁵ In instances such as these, the appropriate response to manufacturers who break the rules is not increased regulation or harsher punishment, but chastisement that is louder and more visible. Patients and healthcare providers simply need to be reminded that the regulatory body that exists to protect them is still doing its job, and that physicians and pharmacists can be trusted to take all relevant factors into consideration when deciding on a course of therapy.

SOURCES:

1. Select USA. The Pharmaceutical Industry in the United States. Available at: http://selectusa.commerce.gov/industry-snapshots/pharmaceutical-industry-united-states. Accessed January 4, 2014.
2. CBS News. Leading generic drug maker faked test results for FDA approval. Available at: http://www.cbsnews.com/news/leading-generic-drug-maker-faked-test-results-for-fda-approval/. Accessed January 3, 2014.
3. The United States Department of Justice. Justice News: Generic Drug Manufacturer Ranbaxy Pleads Guilty and Agrees to Pay $500 Million to Resolve False Claims Allegations, cGMP Violations and False Statements to the FDA. Available at: http://www.justice.gov/opa/pr/2013/May/13-civ-542.html
4. Allen L, Popovich N, Ansel H. Pharmaceutical Dosage Forms and Delivery Systems. Baltimore (MD): Lippincott Williams & Wilkins; 2011:29-30
5. US Food and Drug Administration. FDA News Release: FDA prohibits manufacture of FDA-regulated drugs from Ranbaxy’s Mohali, India, plant and issues import alert Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm368445.htm