Cutting the Drug Development Red Tape
MJH Associates, Inc & the FDA are both committed to eliminating inefficiencies and hype to deliver the most timely and relevant information to health care providers.
At MJH Associates, Inc, one of our key tenets is to cut down on bureaucracy. This means that every associate, no matter their position, has access to senior leadership. This “open door” policy was implemented to reduce the time employees spend waiting for approvals, feedback, and suggestions, ensuring that they can continue the innovative work that we do to achieve our mission: improving quality of life through health care research, education, and communications.
US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, is enforcing a similar tactic. In January, Dr. Gottlieb began cutting the red tape when he announced the launch of a pilot program evaluating how information on drugs in development is released to health care, scientific, and patient communities. In a statement, he said that the FDA is committed to “enhancing transparency about the work we do, especially when it has the potential to foster further research and discovery across the scientific community, and better inform patients and providers.”1
Dr. Gottlieb’s recent move throws his support behind President Trump’s new plan, American Patients First, which aims to lower drug prices by focusing on increasing transparency and competition and dismantling what Time describes as “the convoluted system of rebates between drugmakers and the health care middlemen known as pharmacy benefit managers.”2 The FDA commissioner applauded the president for “introducing a bold plan that puts patients first in advancing actions to address the rising list prices of prescription medicines.” He also reinforced the agency’s commitment to removing barriers faced by generic drug developers to encourage competition to lower drug prices and increase access to these medications through the Drug Competition Action Plan.3
At MJH, we will continue to do the same, eliminating inefficiencies and hype to deliver the most timely and relevant information directly to you, the provider, and your patients through publications such as Contagion® and its website (contagionlive.com) and social media channels (Contagion_Live on Twitter and ContagionLive on Facebook). Ultimately, we share the same goal—improving patient outcomes. Together, let’s commit to cutting the fat and making a difference.
Stay informed, and thanks for reading!
Mike Hennessy, Sr
Chairman and CEO
References
- FDA Commissioner Scott Gottlieb, M.D., on new steps FDA is taking to enhance transparency of clinical trial information to support innovation and scientific inquiry related to new drugs [press release]. Silver Spring, MD: Food and Drug Administration; January 16 2018. fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm592566.htm. Accessed May 23, 2018.
- Perone M, Colvin J. President Trump’s plan to lower drug prices spares pharma industry. Time website. time.com/5275168/trump-plan-lower-drug-prices/. Published May 12, 2018. Accessed May 23, 2018.
- Statement from FDA Commissioner Scott Gottlieb, M.D., on the Trump administration’s plan to lower drug prices. Silver Spring, MD: Food and Drug Administration; May 11, 2018. fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm607495.htm. Accessed May 23, 2018.
