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Acting Commissioner Ned Sharpless Affirms Commitment to FDA’s Current Course

Written by: | news@biospace.com | Dated: Wednesday, April 17th, 2019

 

As Ned Sharpless takes over as acting commissioner of the U.S. Food and Drug Administration (FDA), he is not planning any disruptions or course corrections to the federal regulatory agency.

In remarks to staff on Tuesday, Sharpless, who had been heading up the National Cancer Institute, said he plans to “maintain FDA’s current course of action in every area and proceed full-speed ahead,” according to a statement issued by the FDA.

“So let me reassure you, I am not planning any radical changes from what the FDA has been trying to accomplish,” Sharpless said in his remarks. However, he did add that there will likely be “course adjustments” as new facts appear, but said he walked into an organization “on a good trajectory.”

Sharpless took over the reins of the FDA from Scott Gottlieb, who resigned from the post after two years on the job in order to spend more time with his young family.

Sharpless said the FDA will continue on a mission to increase drug competition and “reign in prescription drug costs” through the generic drug and biosimilar programs that have been established at the agency. Additionally, Sharpless said the FDA under his guidance will continue to do what it can to help streamline the development of new treatments while “ensuring that we maintain FDA’s gold standard of safety and efficacy.”

As acting commissioner, Sharpless, who is well known for his deep understanding of oncology and big data. Said he has a commitment to science-based decision-making and will prioritize the FDA’s efforts to benefit the public health. As an example, Sharpless said he has seen how some charlatans will sell “false hope” to cancer patients and those suffering from other deadly diseases. He said it is important that the FDA continues to stand up for the consumer and expose fraudulent products. Prior to Sharpless taking over at the FDA, the agency issued a number of statements and warnings about the use of unauthorized stem cell products in various treatments.

Sharpless also noted that, while he is fascinated with the groundbreaking work being conducted in biologics, he said it will be important for the FDA to remain vigilant. He said the FDA will not tolerate “dangerous stem cell clinics claiming to treat age-related conditions with highly dubious and unproven cellular products.”

The FDA has also used its authority in recent months to crack down on clinics offering these types of claims. In February, the FDA raised the alarm about clinics using plasma infusions from young donors as a way to help older people maintain a young and healthy look.

One area where Sharpless said he plans to take a lead at the agency is in hiring. He said that in order for the FDA to “remain great and reach its full potential,” then the agency will have to continue to build a “diverse and talented workforce.”

“We need to do this to ensure that we keep up with the scientific and technological changes that have such an impact on the work we do. We will have to do more to recruit and retain the best people and fill the many vacancies, and I have some ideas on this,” Sharpless said.

Promoting the importance of vaccination is also high on Sharpless’ to-do list as acting commissioner. He said he is committed to supporting communications about the efficacy of vaccines to prevent infectious diseases like influenza, HPV, and measles, and to facilitate their broad use.

 

 

BioSpace source:

https://www.biospace.com/article/ned-sharpless-affirms-commitment-to-fda-s-current-course

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