Aveneu Park, Starling, Australia

Over non-generic lifesaving drugs ranging from treatments

Over the past decades 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 a new treatment, they had patent protection which successfully dominated
the market. That was the payment for the high costs and risks for creating innovative
drug therapies. But once the patent and the select grasp on the market ends, any
drug company would be able to produce non-brand name forms of the same drug–so-called
“generics.” And for a time, the method worked efficiently. The technique
intended to incentivize drug companies for their innovation, is methodically
being destroyed.

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Drug 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. Turing Pharmaceuticals, raised the cost of Daraprim,
more than fiftyfold to seven hundred and fifty dollars a pill. Citizen
petitions suggest drug manufacturers another method to delay generics from
being acceptable. These request from the Food and Drug Administration to suspend
action on awaiting generic drug request. By law, the FDA is obligated to highlight
these requests. However, these concerns are not 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 hundred-fifty days.   Pharmaceutical
companies are now using a set of tactics to make their provisional dominations consistent.

Eradicating these strategies will not be easy. Primarily, restraining circulation
agendas need to be blocked. Corporations that produce generic version must be permitted
to buy tastes of these 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 translucency “may have produced a market situation in which
quality problems have become sufficiently common and severe to result in drug
shortages and surged prices.” 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 unfulfilled, and it’s costing customers. 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.






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