Yesterday (November 7, 2022), after Lauren Lempert finished working on our letter to the Regan-Udall Foundation raising issues about the FDA’s scientific standards for assessing premarket tobacco product applications, she browsed the Foundation page listing all the comments that had been submitted to the Expert Panel. The picture that emerges from looking at just a few of these comments from anonymous FDA employees is that the policy and law management folks interfere with the scientific evaluation, which is not given enough time, not based on expertise, and overruled anyway.
This permissive treatment of e-cigarettes is exactly what we’ve seen in our earlier TPL reviews (Vuse Solo, NJOY, Logic) and giving the companies a pass on treatment of shelf life), which is exactly what one might expect after seeing the Holman memo in which the head of the FDA CTP Office of Science prejudged e-cigs are appropriate for the protection of public health.
I went to look over the comments this morning (November 8, 2022), but the RU Foundation had taken them down.
Here are the comments Lauren had downloaded yesterday. All the comments used to be available at https://reaganudall.org/comments-all/6251?page=0. A copy of the first one is available on the Internet Archive.
If these comments reflect reality inside CTP, Director Brian King has his work cut out for him if he wants to make good on his promise to restore science as the core for decision making at FDA.
https://reaganudall.org/comments/319#comment-319
Fdastaff 11-07-2022 09:15
Sat, 11/05/2022 – 15:23
Regulations and guidance
Guidance for PMTAs is limited, for both staff and industry. The PMTA Final Rule has requirements that don’t make sense and could not be followed in practice. Rules and guidances need to be updated quickly, now that FDA has more experience with PMTA review. The guidance needs to make clear how applications are evaluated, not just what types of information are required. Management needs to allow the right subject matter experts to participate in the rule making process, instead of limiting it to their favorite people.
Application review
Application review is stressful and chaotic for scientific review staff. Not enough time is given for the scientific review process, most of the review time for an application is spent with management, policy groups, and lawyers. Management gives little guidance on how to review applications. The burden of decisions is placed on the reviewers and then criticized by many layers of management and non-scientific staff. CTP needs to define the APPH standard and give instructions for each discipline. This should all be made transparent to industry and be grounded in science.
Strengths and challenges
Strengths:
– Reviewers with strong scientific backgrounds, willing to take on extra work and adapt to changing priorities
Challenges:
– Incompetent, top-down management
– Mid-level managers that demand agreement and follow executive leadership without question
– Culture of micromanagement
– Constant turnover, low employee morale, high workloads
Stakeholder Group
FDA staff
https://reaganudall.org/comments/307#comment-307
Fdastaff 10-31-2022 16:49
Mon, 10/31/2022 – 10:03
Regulations and guidance
1- Act swiftly on finalizing tobacco product standards for NNN levels in smokeless tobacco, banning menthol in cigarettes and flavors in cigars, and reducing nicotine levels in tobacco products.
Application review
1- ensure that all comments from scientific reviewers are communicated to the applicants
2- improve transparency by publishing relevant scientific reviews, if FOIA’d
3- Streamline the review process that are currently all over the place and keep changing regularly
3- limit the strict involvement of the policy staff in the scientific reviews. their involvement should only be relevant to FDA policy and should not limit comments from the reviewers
4- Ensure that review processes are written by Only scientific reviewers who actually performed application reviews, no seasonal reviewers
Compliance and enforcement
1- Stronger and faster enforcement strategies for non-compliance
2- enforce good manufacturing practice for tobacco productions
Communication with the public and other stakeholders
Better communication with the public about risks of tobacco products. Relying on social media ads and videos has proven to be effective but also having FDA staff present and interact with high- and middle- school students on these issues can improve communication.
Develop more public and industry meetings related to reviews and involving newer faces in these efforts.
Strengths and challenges
FDA has very strong scientific reviewers with proven expertise. They just need more autonomy in exercising their scientific views
FDA needs to take better advantage of the skills of CTP staff. Many staffers are overworked while others are not doing much, or their skills are not utilized to full extent. OS leadership is also favoring some staff over others and had created a toxic environment where good staff are looking for other opportunities outside CTP. Projects or positions had been created just to promote favored people over others who are hard-working and, therefore, staff morale is very low.
Stakeholder Group
FDA staff
https://reaganudall.org/comments/308#comment-308
Fdastaff 10-31-2022 16:49
Mon, 10/31/2022 – 10:04
Regulations and guidance
Progressively it has become harder to work due to top-down approach. It has been frustrating to see a lack of clear guidelines and regulations after so many years of ENDS on market. Tobacco companies are exploiting loopholes and lack of clear guidelines to their advantage by flooding the center with incomplete and unnecessary information. Applications that lack even basic scientific information have to be scientifically reviewed causing overload and burnout. All new products should be required to be off the market till they submit complete applications.
Application review
There is lack of scientific discussion in the application review. Most staff have very short turn-around times and are overworked. However, work is also unequally distributed, not based on expertise but on availability. Staff professional development and education is sidelined due to lack of budget.
Compliance and enforcement
As an agency, we have had no major enforcement efforts to take product of the market
Communication with the public and other stakeholders
Poor communication to all stakeholders, including academic research and applicants on the needs to scientific review. Lack of strict enforcement on tobacco companies
Also, the continuous barrage of lawsuits from tobacco industry to avoid graphic warning, and regulation of cigars needs to be clearly communicated to the public. Tobacco companies cannot be in harm reduction and be manufacturing cigarettes and resisting public health education in the same breath.
Strengths and challenges
Challenges: Collaborations are discouraged due to unnecessary paperwork. Lack of trained staff, overload of administrative tasks, lack of incentive to do good job, lack of motivation, too much bureaucracy, top down management. Lack of leaders who look at the big picture and motivate to do the best
Strength: Staff are driven by the public health mission and importance of regulating tobacco for the next generations.
Additional comments
Leadership change is due. Scientific discussion and staff actively in the scientific process is lacking.
Additional staff are needed
Expert staff are leaving because of lack of recognition, disagreement with management over science policy and lack of retention incentive
Additional budget to train and keep up professional development of staff
More women and minority leaders needed. Open collaboration with academic institutes to find solution to important regulatory questions
Stakeholder Group
FDA staff
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