FDA Commissioner, Scott Gottlieb, introduced his plan for helping reduce drug-development costs while speaking at the 2017 RAPS annual conference held on September 11-12 in Washington DC.
Here are highlights of his plan for the FDA to help reduce costs related to drug development and drug approval.
- Improve the efficiency of the early stage (pre-clinical) of drug development
- Modernize the agency’s workflow and drug-review process
- Streamline the process of how the agency collects clinical information
- Modify traditional clinical trial designs and utilize adaptive and “seamless” approaches, such as combined-phase studies (eg, a large, continuous trial for one developmental drug with potentials for multiple indications)
- Advance the use of “Master Protocols”
- Encourage communication between all stakeholders involved in drug development
- Utilize the power of high-performance computing and harness the potentials of AI
To help lower overall drug prices, Gottlieb noted that the industry and the FDA need to
- Bring more competition, including generic competition, to the drug market,
- Improve the efficiency of the drug development process, and
- Take actions to prevent companies from gaming the system to “extend their drug monopolies.”
Click here to access his full speech.