Referencing the scenario, describe the executive branch authority used by the FDA in reclassifying insulin as a biologic and explain how this use of the FDA's authority might affect the success of the Biologics Price Competition and Innovation Act

Answer from: mandy9386

The Food and Drug Administration (FDA) is the federal agency responsible for the approval, regulation, and control of prescription medications. All prescription medications must complete an extensive FDA approval process, which can take years. In an attempt to expedite this process, Congress passed the Biologics Price Competition and Innovation Act in 2009, which created a faster approval pathway for biologic products that are highly similar to existing FDA-approved medications. The law applies only to biologic products, those produced with living organisms, but not to chemically produced drugs. Insulin is a vital prescription medication used to treat diabetes. Over an eight-year period, beginning in 2009, the average price of insulin increased from $90 to $275 a vial. Since insulin was not regulated as a biologic, the time necessary to gain FDA approval prevented new companies from developing less expensive alternatives.

In 2017, public attention to the rising cost of insulin led the FDA to reclassify the drug as a biologic, thereby lessening the amount of time it took for new companies to get FDA approval. With more manufacturers competing in the marketplace, prices would likely drop.

Referencing the scenario, describe the executive branch authority used by the FDA in reclassifying insulin as a biologic and explain how this use of the FDA’s authority might affect the success of the Biologics Price Competition and Innovation Act.

The rise in public opinion for the reclassification of insulin influenced the FDA’s decision and served to strengthen the act

Explanation:

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the neutrality acts were passed by the united states congress in the 1930s, in response to the growing turmoil in europe and asia that eventually led to world war ii. they were spurred by the growth in isolationism and non-interventionism in the us following its costly involvement in world war i, and sought to ensure that the us would not become entangled again in foreign conflicts.

the legacy of the neutrality acts is widely regarded as having been generally negative: they made no distinction between aggressor and victim, treating both equally as "belligerents"; and they limited the us government's ability to aid britain and france against nazi germany. the acts were largely repealed in 1941, in the face of german submarine attacks on u.s. vessels and the japanese attack on pearl harbor.

music always has an important role in culture and societies, infact for example rock’n roll music has conditioned different areas of pop culture above all in the 60s. in the modern american society its role is different.

unfortunately many think about how some unfortunate events happened to the columbine high school shootings can be related to rock music just because the teenagers involved listened to this kind of music.

i think that we can valorize the change to take refuge in this genre of music to keep on in everyday life, teenagers are comfortable when they can listen to a song about a specific problem. realizing that someone else is living your personal drama too can them to feel less lonely nowadays.