Guidelines for Optimal Design and Administration, Essay Example

“H.R. 6: 21st Century Cures Act” had been proposed by Republican Fred Upton on May 15, 2015 and was passed by the House of Representatives on July 10, 2014. The purpose of the bill is to reform standards that currently regulate biomedical research. Specifically, it would “provide $1.75 billion annually for the National Institutes of Health (NIH) and $110 million for the Food and Drug Administration (FDA)” (GovTrack, 2015). In addition, this legislation would expedite the testing of experimental drugs. The bill received bipartisan support and has been sent to the Senate for a final vote.

This bill was selected because there is a significant need to contribute funding to research to help support the development of new cures and treatments for patients with a variety of illness. Therefore, it is beneficial for this bill to be passed because it provides extra funding to two major health care regulatory institutions in the country. In addition, expediting the testing of experimental drugs will contribute to FDA approval in a manner that will allow these drugs to potentially save a greater number of lives. The clinical testing of pharmaceuticals is a lengthy process that is necessary to ensure the safety of drugs, but is often not thorough (Edwards, 2010). Therefore, it would be helpful for additional funds to be provided by researchers to help increase the speed of the process while continuing to ensure the safety of these drugs.

To prepare legislative testimony for this type of legislation, it would be helpful to understand the drug discovery and testing process in addition to statistics related to the amount of individuals that could reasonably benefit from experimental drugs (Darrow et al., 2015). The fact that this legislation was passed by both Democrats and Republicans shows that access to medical care is an important issue for both parties.

References

Darrow, J.J., Sarpatwari, A., Avorn, J., Kesselheim, A.S. (2015). Practical, Legal, and Ethical Issues in Expanded Access to Investigational Drugs. The New England Journal of Medicine, 372:279-286.

Edwards, P. (2010). Questionnaires in clinical trials: guidelines for optimal design and administration. Trials, 11(2).

GovTrack. (2015). Summaries for the 21st Century Cures Act. Retrieved from https://www.govtrack.us/congress/bills/114/hr6/summary