the past decaden, prices for various non-generic lifesaving drugs ranging from treatments
for anaphylactic reactions such as epinephrine to deflazacort, a medicine for
Duchenne Muscular Dystrophy, have skyrocketed. The 1984 Drug Price Competition
and Patent Term Restoration Act gave pharmaceutical companies exclusive
protections for formulating a new drug. If they created an original treatment,
they had patent protection, which allowed them to dominate the market. That was
the payment for the high costs and risks entailed in creating innovative drug therapies.
But once the patent and the select grasp on the market ended, any drug company
was able to produce non-brand name forms of the same drug–so-called “generics.”
And for a time, the method worked efficiently. However, the technique intended
to incentivize drug companies for their innovation is methodically being destroyed.
companies, the creators of the original therapies, are demolishing competition
through various maneuvers, and the outcome is extreme prices, beaten competition,
and treatment quality issues. One method drug manufacturers use to prevent
competition is “pay for delay” agreements where a brand drug company pays off a
generic company not to launch a version of a drug. According to the Federal
Trade Commission these contracts cost the American consumers an estimate of
three and a half billion dollars in high drug costs each year. From 2009 to
2016, Mylan increased the price of a two pack EpiPen from a hundred to six
hundred dollars. Valeant in 2011 abruptly raised the price of isoproterenol
from $440 to around $2,700 a dose. Marathon Pharmaceuticals increased the price of Emflaza, to eighty-nine thousand dollars–a six thousand percent price rise. And Turing
Pharmaceuticals raised the cost of Daraprim more than fiftyfold to seven
hundred and fifty dollars a pill.
Citizen petitions requesting that the Food
and Drug Administration delay generic drug requests offer drug manufacturers
another method to delay generics from entering the market. By law, the FDA is obligated
to highlight these requests. However, these concerns are not actually being filed
by individuals, but rather by corporations. The FDA recently stated branded
drug manufacturers proposed ninety-two percent of all requests. Many of these applications
are filed near the date of the patent expiration, effectively preventing possible
competition for at least another 150 days.
companies are now using a set of tactics to maintain their monopolies forever. Eradicating
these strategies will not be easy. Corporations that produce generic drugs
must be permitted to acquire samples of new treatments to perform
bioequivalence reports. Next, pay-for-delay arrangements should be taken away, including
a company’s capacity to issue citizen petitions with the intent of delaying opposition
from generic companies. Imposing and encouraging high-quality standards for treatments
must also be an industry requirement. To create transparency around medication value,
the FDA has offered a system of grade marks for drug plants. In a financial
study, lack of transparency “may have produced a market situation in which
quality problems have become sufficiently common and severe to result in drug
shortages and surged prices.” (“Shining a light on prescription drug pricing”,
2017) Another way to achieve greater transparency in medication quality is to
change the product labeling rules. Labels should reveal the medication’s creator.
As of now, pharmacies and hospitals don’t always know which establishment
actually produced the treatment. This makes it difficult to determine purchase
decisions on quality.
Generic medicines can provide great
benefits for patients and health systems when there is sufficient competition
and quality, but their potential is currently unfulfilled, and it’s costing consumers.
By eradicating preventive dispersal arrangements, pay-for-delay, and civilian
petitions, as well as providing more transparency around value, politicians,
doctors, hospitals, and the heads of the FDA have a strong opportunity. They can
start to reverse rising health care costs and ensure quality medications are
accessible to the American population.