Running head: FDA Regulation of Drugs
FDA Regulation of Drugs:
Under-regulation or Over-regulation?
Blanka Hodur
University of California - Davis
FDA REGULATION OF DRUGS
Abstract
The Sulfanilamide and the Thalidomide tragedies illustrate the critical role the FDA plays
in our society in ensuring the safety and efficacy of drugs. Even though the pharmaceutical
industry is one of the most regulated industries in the United States, some individuals believe the
FDA is under-regulated (Carpenter, 2004). However, while safety is rightly a concern, too much
of an emphasis on safety has caused over-regulation that has damaged innovation. Unfortunately,
not only do pharmaceutical companies suffer from over-regulation but also individuals, and their
families, seeking life-saving treatments. Over-regulation by the FDA has allowed the suffering of
countless individuals by hindering the accessibility of drugs to these individuals in desperate
need for treatment.
FDA REGULATION OF DRUGS
FDA Regulation of Drugs:
Under-regulation or Over-regulation?
Modern drug regulation by the Food and Drug Administration (FDA) began in response
to the Sulfanilamide tragedy of 1937. In an attempt to treat sore throats, a drug was created that
combined sulfa powder with diethylene glycol, the latter a deadly poison. However, the drug did
not undergo any clinical testing before becoming available on the market, and due to this, it
killed 107 people. This tragedy caused the passing of the Food, Drug and Cosmetic Act that
makes it so that a manufacturer of a drug has to submit a New Drug Application (NDA) to the
FDA. The FDA then determines the safety of the drug before it can enter the market. Further, the
Thalidomide tragedy in Great Britain, in which a drug to treat morning sickness was found to
have caused numerous birth defects, contributed to the further passing of the Kefauver-Harris
Amendments. These amendments make it so that manufacturers have to obtain “substantial
evidence” that there drug is safe and effective. Further, manufacturers must receive approval by
the FDA before starting any human trials of their drug (VanHuysen, 1997).
The Sulfanilamide and the Thalidomide tragedies illustrate the critical role the FDA plays
in our society in ensuring the safety and efficacy of drugs. According to the Food and Drug
Administration, their mission is to “promote and protect the public health by helping safe and
effective products reach the market in a timely way, and monitoring products for continued
safety after marketing” (About FDA, 2014). Even though the pharmaceutical industry is one of
the most regulated industries in the United States, some individuals believe the FDA is underregulated (Carpenter, 2004). However, while safety is rightly a concern, too much of an
emphasis on safety has caused over-regulation that has damaged innovation. Unfortunately, not
FDA REGULATION OF DRUGS
only do pharmaceutical companies suffer from over-regulation but also individuals, and their
families, seeking life-saving treatments. Over-regulation by the FDA has allowed the suffering of
countless individuals by hindering the accessibility of drugs to these individuals in desperate
need for treatment.
Claims of Under-regulation
A major concern for those individuals who claim that the FDA is under-regulated is the
dangerous consequences seen by inadequate regulation of foreign imports of drugs. While a
staggering 80% of active pharmaceutical ingredients in drugs are manufactured outside of the
United States, the FDA reviews less than 1% of these imports (Reiser, 2009). The FDA, with
lack of funding, is unable to keep up with the increased rate of US pharmaceutical companies
outsourcing their drug manufacturing to India and China. The motive behind this outsourcing by
pharmaceutical companies is to save on the expense of producing drugs at home. One example of
an imported drug that caused negative effects is heparin. Heparin, an anti-coagulant imported
from China used to prevent blood clots, is believed to have killed 81 Americans. It was later
found that the heparin was contaminated with a compound called oversulfated condroitin sulfate
because it is much cheaper to manufacture. Incidents like this cause individuals to believe that if
drugs are going to continue to be imported from other countries more stringent international
regulation needs to be implemented to ensure the safety of patients (Reiser, 2009).
The effects of the Prescription Drug User Fee Act (PDUFE), passed in 1992, raise further
concerns for individuals who believe that the FDA is under-regulated. PDUFE makes
pharmaceutical companies pay part of the cost for the drug approval process in an attempt to
decrease the time it takes for drugs to be approved. Individuals argue that shorter approval times
FDA REGULATION OF DRUGS
have caused an increase in adverse effects caused by drugs because the decreased incentive of
pharmaceutical companies to conduct large-scale safety trials after approval. Mary K. Olson, an
economist at Yale University, found an association between decreasing the approval time by one
month and an increase by 2% of deaths believed to be caused by adverse drug reactions. For
example, eight years after Avandia, a drug used to treat diabetes, became available it was found
that the drug increased the risk of heart attacks in patients. It is argued that drug approval times
should be longer in order to provide more time to assess the safety of drugs to prevent incidents
like that of Avandia (Reiser, 2009).
Claims of Over-regulation
Over the past decades the FDA has increased regulation in an attempt to prevent such
incidents as those mentioned above. However, some accuse the FDA of going too far and
actually over-regulating the drug industry. One of the major claims of over-regulation is that the
FDA does not emphasize the efficacy of drugs enough, focusing too much on safety (De Maria,
2009). One of the reasons the FDA under emphasizes efficacy versus safety is that the
occurrence of side effects cause much more attention than the treatment of diseases, with no
attention paid to the disapproval of drugs. Thus, the FDA has a disposition to disapprove a drug
rather than approve it and potentially be criticized later on (De Maria, 2009; Laubach 1980). For
example, De Maria (2009) brings up the case of Vioxx, which was withdrawn due to increased
risk of cardiovascular side effects (McClellan, 2007). However, many physicians, upon hearing
of the withdrawal, hoarded it believing that the benefits of Vioxx, in small doses, outweighed its
risks. This suggests that the FDA put too much emphasis on safety. They ignored the potential
FDA REGULATION OF DRUGS
benefits of keeping Vioxx available to patients who are willing to take the risk in order to obtain
treatment (De Maria).
Further, this overemphasis on safety has had a negative effect on innovation. The vast
technological advances in the past decades have made it possible for the pharmaceutical industry
to produce more drugs faster. These drugs are extremely important in our society. For example,
modern drugs have provided treatments for many once very serious infections and diseases.
Drugs have led to a decrease in the number of patients in mental hospitals, made cases of polio
pretty much nonexistent and decreased death caused by cardiovascular diseases among countless
other immense benefits (Laubach, 1980). However, despite these great benefits of drugs and
recent technological advances, Laubach (1980) argues that pharmaceutical companies are not
meeting their full potential.
The long approval process makes it so that pharmaceutical companies underperform due
to economic risks (Laubach, 1980). The approval process for just one drug is estimated to cost
between $300 and $500 million for pharmaceutical companies. This cost is accumulated whether
or not the drug is even approved, and only one in 5,000 to 10,000 are approved. This creates a
great financial risk for pharmaceutical companies to develop a drug because they have to invest a
lot of time and money into a drug that is likely to not be approved. Therefore, not as much
research is put into new drugs despite technological advances, and not as many drugs are being
designed than is potentially possible (VanHuysen, 1997). Further, once a drug has beat great
odds and actually been approved it is likely that already half of the patent life of the drug is gone
due to the long approval time. With the immense amount of money spent on developing the drug
there is little time left for obtaining profit since once the patent expires cheaper generic copies
FDA REGULATION OF DRUGS
become available (Epstein, 2007). Further, not only do pharmaceutical companies have to cover
the cost of developing the one drug that got approved but also the costs of all the other drugs
they developed that were not approved. As mentioned earlier, pharmaceutical companies
outsource in order to relieve some of this cost (Reiser, 2009). Thus, if the cost of producing new
drugs was relieved by a shorter drug approval process, then less drugs would be outsourced
relieving the danger of under-regulation abroad.
This decreased innovation and long time for the approval of new drugs hurts patients who
do not have access to these drugs that could potentially help treat them. While the FDA may not
be willing to risk their reputation on a potentially unsafe drug, many of these patients are in a
situation in which they are willing to take the risk in hopes of treatment (Epstein, 2007).
VanHuysen (1997) argues that the willingness of patients to take this risk is evident in the fact
that many will go to other countries that have approved the drug in order to get treatment. In fact,
this is the very reason that PDUFA was passed: AIDS activists argued that the FDA was slowing
down the development of live-saving drugs to treat AIDS (Reiser, 2009). Epstein (2007) argues
that a large number of drugs, for things like cancer, that have not obtained FDA approval are on
off-label use with little evidence of any decreased safety, suggesting they are just as safe as any
FDA approved drug. According to VanHuysen (1997), this causes a lost profit of $1.5 to $3
billion a year. Pharmaceutical companies put some of the cost of developing the drug onto the
consumers by increasing the price of the drug to patients before generic copies become available.
This causes the possibility that patients are not able to afford treatment even when it is available.
Simply, if the process of developing drugs was less costly, drug companies would introduce
more new drugs to the FDA to be approved that would be able to be obtained at a lower cost.
FDA REGULATION OF DRUGS
Conclusion
De Maria (2009) writes, “In ‘a catch 22’, the FDA has received criticism for both
delaying the availability of new therapies and for allowing drugs and devices to be approved
before fully documenting their safety” (p. 1761). Undoubtedly, safety is an important concern of
the FDA in the regulation of drugs in order to avoid a repeat of tragedies like the Sulfanilamide
tragedy. However, the FDA’s overemphasis on safety neglects the potential benefits that can
come from getting more drugs on the market faster. With no treatment available, life-threatening
diseases take the lives of countless Americans every year. However, the FDA is too slow to
approve drugs that could potentially provide treatment to prevent these deaths. Further, their
strict regulation discourages pharmaceutical companies from taking risks in the development of
new drugs, thus halting advances in new drugs that can treat these diseases. Cases like that of the
Sulfanilamide tragedy and heparin were caused by little to no regulation, drugs can still be
appropriately regulated without constantly disapproving drugs and increasing approval times.
Even if loosening regulation comes with a slight increase in the number of unfortunate tragedies
with new drugs, individuals with life-threatening diseases do not stand a chance against their
disease if nothing is available to them. Arguably, many more deaths will come from untreated
diseases than the occasional drug tragedy in which the drug is quickly taken off the market.
Further, even with less regulation it is still in the interest of pharmaceutical companies to develop
safe drugs so as to not gain a bad reputation of producing unsafe drugs, regardless of regulation.
Lastly, loosening up on regulation will put less economic stress on pharmaceutical companies
and make drugs that are on the market more affordable and available to patients.
FDA REGULATION OF DRUGS
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