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FDA leadership change – Issue

Following the departure of Scott Gottlieb, MD, Norman “Ned” Sharpless, MD, became acting FDA Commissioner on April 5, 2019. Considering the impact the U.S. Food and Drug Association (FDA) regulations have oneach of us, you may be wondering if this leadership change might result in any policy changes related to the government agency’s regulation of “a wide range of products, including foods (except for aspects of some meat, poultry and egg products, which are regulated by the U.S. Department of Agriculture); human and veterinary drugs; vaccines and other biological products; medical devices intended for human use; radiation-emitting electronic products; cosmetics; dietary supplements, and tobacco products.

Note that the quotes following each article referred to below are excerpted to reflect Dr. Sharpless’ career experience, personal interests, and FDA actions since April.

Acting Commissioner Ned Sharpless Affirms Commitment to FDA’s Current Course (4/17/19)
by Alex Keown
“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 said the FDA under his guidance will continue to do what it can to help streamline the development of new treatments…
Promoting the importance of vaccination is also high on Sharpless’ to-do list as acting commissioner.

FDA Public Meeting on Responsible Innovation in Dietary Supplements (5/16 /19)
We’ll continue to protect consumers by cracking down on false, misleading, and potentially harmful claims.
This past February, FDA announced some new steps we’re taking to advance our regulation of dietary supplements and modernize and reform our oversight of this important segment of our health economy. I want to assure you that this work remains a priority and will continue.
We’re also committed to taking action when products contain ingredients that render the products unlawful, including many drug ingredients, and when they’re not manufactured according to standards designed to ensure a quality product.
Last month, we announced the Dietary Supplement Ingredient Advisory list, a new rapid-response tool that we’ll use to alert the public when ingredients found in dietary supplements appear to be unlawful, based on our preliminary determination.
We also recently announced a Botanical Safety Consortium that we’re kicking off with our industry, academic, and government partners to promote scientific advances in evaluating the safety of botanical ingredients and mixtures in dietary supplements.

Statement from Acting FDA Commissioner Ned Sharpless, M.D., and Deputy Commissioner Frank Yiannas on steps to usher the U.S. into a new era of smarter food safety (4/30/19)
…we recognize that it’s time to look to the future of food safety once again… That’s why, today, we’re announcing a “New Era of Smarter Food Safety” to augment our efforts implementing important FSMA requirements…
The use of new and evolving digital technologies may play a pivotal role in tracing the origin of a contaminated food to its source in minutes, or even seconds, instead of days or weeks, when contamination does occur. 

How FDA is Regulating E-Cigarettes (7/9/19)
After years of witnessing a steady decline in the use of tobacco products by children and young adults, we are now seeing a rapid resurgence of the use of tobacco products in these populations. 
And while ENDS products appear to hold some promise in helping addicted adult smokers transition away from combustible tobacco to a potentially less harmful form of nicotine delivery, these products are not safe, and we cannot allow the next generation of young people to become addicted to nicotine.

Statement on stem cell clinic permanent injunction and FDA’s ongoing efforts to protect patients from risks of unapproved products (6/25/19)
On June 3, 2019, the Courtgranted the government’s motion for summary judgment after concludingthat the defendants adulterated and misbranded their cellular products made from patients’ adipose tissue.
For sponsors whose stem cell products are subject to premarket approval under the statutes and existing regulations, … we’ll continue our aggressive oversight, prioritizing resources to address those clinics, individuals and products that put patients most at risk.

Pink Sheet – New Acting US FDA Commissioner Shares Agency’s Clinical Trial Reform Message (3/12/19)|
by Derrick Gingery
Friends of Cancer Research
The US FDA’s incoming acting commissioner shares an enthusiasm for clinical trial system reform that should mesh well with the message many senior agency officials have been pushing for years.
Sharpless is a proponent of increasing clinical trial efficiency, including by eliminating unnecessary exclusion criteria and encouraging wider trial access. In a 2018 interview with the American Association For Cancer Research, Sharpless said he wanted to prioritize trials that avoid diluting the participant pool and designs that will find ineffective treatments faster.

Ned Sharpless, director of the National Cancer Institute, to be named acting FDA commissioner (3/12/19)
by Lev Facher
“Dr. Sharpless’ deep scientific background and expertise will make him a strong leader for FDA,” Azar said in a statement. “There will be no let-up in the agency’s focus, from ongoing efforts on drug approvals and combating the opioid crisis to modernizing food safety and addressing the rapid rise in youth use of e-cigarettes.”
Sharpless is also familiar with the biotechnology industry and the drug-development process. He has co-founded two early-stage biotech companies: G1 Therapeutics, a developer of cancer drugs that raised $108.6 million in a 2017 initial public offering, and HealthSpan Diagnostics, a developer of blood tests.

Feds Loosen GMO Rules (7/8/19)
Alliance for Natural Health
This follows a proposed rule issued early in June that loosens requirements that certain GE plants must follow. These actions will make it easier for Big Food to develop and sell GE food while hiding the fact that it has been genetically modified, thanks to the sham GMO labeling law passed in 2016.

ISSUE: Impact from FDA leadership change?

AHHA strives to maintain a neutral position on issues and viewsknowledge as power. For those interested in this month’s issue, the articles cited above were selected to serve as a foundation for learning more about this matter.

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