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  • Subject area(s): Marketing
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  • Published on: 14th September 2019
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Antonio Almeida

Mr. Naughton

Justice: Economics -6th

01 December 2018

Word Count: 713

Orphan Drugs SJA Part 3

In order to augment the quality of treatment for orphan diseases, its adversary--

corporate greed-- must be minimized by closing loopholes which allow it to run rampant. Profit is the cornerstone of the corporate world and guides the decisions corporations make; often these decisions disregard the well-being of the environment and the general public. Obviously, corporate greed must be curbed, but outside of becoming CEO of such a company, there is not much you and I can do. On the other hand, the government can create markets and tax, subsidize, regulate them with the potential to mitigate rampant corporate greed. Despite the Orphan Drug Act's success in bringing about an unprecedented amount of orphan drugs, yet they need to be redefined.

Congress needs to take revise the ODA to halt the practice of drug repurposing and

salami-slicing, instead refocusing on illnesses which are abandoned due to “financial viability”. The program is being manipulated by drugmakers to maximize profits and to protect niche markets for medicines being taken by millions, and the supposed “gatekeeper”— the FDA— has failed to uphold the rigorous standards which the ODA specifies. One of the FDA's most egregious failures is their compliance with big pharma is their repeated failure to verify the information they're provided with by pharmaceutical companies. FDA's reviewers are supposed to apply two specific criteria — how many patients would be served and whether there is scientific evidence the drug will treat their disease. In nearly 60 percent of the cases, the FDA reviewers didn't capture regulatory history information, including "adverse actions" from other regulatory agencies. Dr. Gayatri Rao, director of the FDA's Office of Orphan Products Development, said "We always talked about how we permit the second bite of the apple, third bite of the apple, as one small way to incentivize repurposing", noting that industry and patient groups have been pressing the FDA for even stronger incentives. "Now, all of sudden, it seems like, wow, this practice may be driving up prices." Rao stated. In order to even begin to resolve the abuses of the system, the agency needs to change its documentation and vetting processes. The repurposing of mass market drugs has actually been detrimental for those who suffer from rare illnesses, economically invalidating them and redirecting potential funding by overwhelming the marketplace. Once a drug exceeds the basic tenets of the act — to treat fewer than 200,000 people — it should no longer receive government support or marketing exclusivity.

The US government has partially upheld its responsibility to the people through its legislation, while failing to close loopholes— however, it shouldn't have ever been necessary to incentivize medicine. It is indisputable that healthcare is a basic human right (e.g. research). According to the personal form, individuals should willingly apply their God-given gifts towards the betterment of society. Practically speaking though , this is unrealistic. The manipulation of the ODA and the FDA's tolerance of it are an affront to the dignity which all people possess. Due to the systemic nature of this issue and the large sums of money involved in R&D, there is little that can be done in the realm of charity outside of donations. In other words, systemic justice must be established. This can be achieved through pricing negotiations, clauses that reduce marketing exclusivity, and the leveling of taxes once a medication becomes a blockbuster treatment for conditions not listed in the original FDA approval. Such measures would ensure that the spirit of the original act is followed while continuing to provide critical economic incentives for truly rare diseases. However, all these changes require the backing of a powerful institution. As an individual, this issue is quite daunting to face. However, orphan drugs are a relatively unknown issue of social justice, and just by opening a dialogue about it with someone, you've introduced someone to a world of conniving corporations. As such a marginalized issue, raising awareness about it is a great place to start. Ideally, capable individuals should research orphan drugs for free, recognizing man as valuable and irreplaceable. In such a world, corporations use their privilege and resources to steward God's creation, and truly accept that, as healthcare providers, they have a responsibility to their consumers to provide the highest quality of care.

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