iPLEDGE advocacy updates

The statements to members below track the Academy’s ongoing advocacy efforts for the dermatology specialty on the iPLEDGE Program.

Feb. 10, 2026

iPLEDGE Win: FDA finally confirms iPLEDGE changes long advocated for by AADA

AADA advocacy culminates in changes reducing physician, patient burden

Following relentless and sustained advocacy by AADA over many years, the FDA approved significant modifications to the iPLEDGE REMS Program that will reduce administrative burdens while maintaining patient safety.

The changes include:

• Allowing at-home pregnancy tests: Prescribers may allow patients to complete at-home pregnancy tests during and after treatment. Pre-treatment tests must be done in a medical setting, and prescribers must establish processes and procedures to minimize the risk of misinterpretation and falsification of at-home test results.

• Removal of the 19-day lockout requirement: If a patient who can get pregnant did not obtain their prescription within the 7-day window, a repeat pregnancy test may be done immediately without an additional waiting period. If the patient has not received their first dose of isotretinoin, the test must be done in a medical setting.

• Monthly counseling documentation removed: Patients who cannot get pregnant must be counseled at enrollment; however, monthly counseling documentation is no longer required.

The modifications should go into effect by mid-August of 2026. Until then, the FDA will exercise enforcement discretion regarding pregnancy testing requirements, allowing prescribers to use pregnancy tests that are not performed in CLIA-certified laboratories, and permit patients to complete and report home pregnancy tests during and after isotretinoin treatment, if procedures are established to ensure accurate documentation of at-home pregnancy test results.

The FDA also issued Q&A on the iPLEDGE REMS, which includes updated information from the announcement.

Dec. 5, 2023

iPLEDGE Win: FDA implements AADA’s recommendations

In response to AADA’s relentless advocacy, the FDA has finally agreed to implement important changes to the iPLEDGE program that will alleviate administrative burdens for dermatologists.

In 2023, 300 AADA members sent about 600 messages to the FDA urging changes to iPLEDGE REMS Program. These grassroots efforts, combined with AADA’s strong advocacy led by its iPLEDGE Workgroup, including testifying during an FDA hearing in March, convinced the FDA to require modifications to the iPLEDGE REMS to minimize burdens on patients and dermatologists while maintaining the safe use of isotretinoin. The FDA will require the Isotretinoin Product Manufacturers Group (IPMG) to implement the following changes to the iPLEDGE REMS:

• Remove the waiting period requirement (also referred to as the “19-day lockout”) for patients if they do not obtain isotretinoin within the first 7-day prescription window. Before initiating isotretinoin treatment, a repeat confirmatory pregnancy test must be completed in a medical setting (as described above) without any required waiting period.

• Revise the pregnancy registry requirement to remove the objective to document pregnancy and fetal outcomes (and associated data collection) for each pregnancy.

• Revise the requirement for prescribers to document patient counseling in patients who cannot become pregnant from monthly to only at enrollment.

• Remove the requirement that pregnancy tests must be performed in a CLIA-certified laboratory; however, all pregnancy testing before isotretinoin treatment initiation must be completed in a medical setting (e.g., prescriber’s office, clinic laboratory). Allow prescribers the option of using home pregnancy testing for their patients during and after isotretinoin treatment. Prescribers who rely on the patient to perform a home pregnancy test need to take steps to minimize patients falsifying the results of these tests. As of Nov. 7, 2023, all pre-treatment pregnancy tests must be performed in a medical setting (e.g., office, laboratory).

For more information, visit FDA’s frequently asked questions.

The IPMG will be required to implement these changes six months from Nov. 30, the date of FDA’s letter. Then, the FDA has six months to review and approve the changes. Once approved, the IPMG will need time to implement the changes. Therefore, these changes may take up to a year or more to be implemented fully.

The AADA has already reached out to the IPMG and FDA and requested to participate in the next phase of this process.

Oct. 13, 2023

FDA extends flexibility for pregnancy tests

The FDA announced it will continue to allow at-home and other non-CLIA pregnancy tests for iPLEDGE. This flexibility will continue indefinitely.  

The pre-treatment, confirmatory pregnancy test must be performed in a medical setting, but additional pregnancy tests may be performed at home or in other settings. 

The AADA long advocated for this flexibility to remain and testified in March at an FDA advisory committee hearing, coordinated with several stakeholder societies, sent numerous letters, and engaged members who sent more than 700 letters to the FDA.

July 25, 2023

AADA weighs in on third-party changes to iPLEDGE REMS 

As a direct result of the AADA’s advocacy efforts, the FDA is requesting feedback the agency should consider when there are certain modifications to a risk evaluation and mitigation strategy (REMS) that are initiated by or related to changes in third-party vendors (i.e. REMS administrators). 

The AADA urged (PDF) the FDA to require input from prescribers at all stages of developing, implementing, and tracking a REMS change. The AADA recommended that the FDA require drug sponsors and their REMS administrators:

• test proposed changes to REMS system before implementation with physicians, patients, and pharmacists;

• allow for ample time for stakeholders to transition to a new platform, including beta-testing;

• improve support services for prescribers when there is REMS System failure; and

• facilitate greater transparency between drug sponsors, REMS administrators, and stakeholders, including a named point of contact for key stakeholders.

Additionally, the AADA organized a sign-on letter (PDF), garnering support from 15 other medical and patient societies.  

May 16, 2023

FDA extends approval of at-home pregnancy tests under iPLEDGE

In an AADA advocacy win, the FDA officially extended certain COVID-19-related flexibilities through Nov. 7, 2023, including accepting at-home pregnancy tests and other non-CLIA tests for the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS). The AADA has been advocating for the use of at-home pregnancy tests under iPLEDGE, most recently at an FDA Advisory Committee meeting. At that meeting, the committee supported permanently allowing non-CLIA pregnancy tests for at-home testing or in-office testing, and the AADA has sent a follow-up letter (PDF) to the FDA requesting that they accept this recommendation and make other necessary changes to the program. Because the flexibility ends on Nov. 7, the Academy has been increasing its advocacy efforts to urge that the FDA make this flexibility permanent.

Reducing the administrative burden of iPLEDGE remains a top advocacy priority, and the AADA continues to press the FDA to make this change permanent. Additionally, the AADA urges the FDA to remove the monthly physician attestation requirements for patients who cannot become pregnant, remove the 19-day “lockout” period if a patient misses an initial window period, and increase transparency and improve the inclusion of stakeholders, including dermatologists in the program.

March 30, 2023

Following AADA advocacy, FDA advisory committees recommend vital changes to iPLEDGE

As a direct result of the AADA’s on-going advocacy to improve the iPLEDGE REMS Program, the FDA held a joint advisory committee meeting this week to discuss ways to minimize burdens in the iPLEDGE REMS Program while maintaining safe use of isotretinoin oral capsules for patients. 

At the meeting, joint advisory committee members voted and discussed key changes to the program. Overall, their recommendations are aligned with the AADA’s recommendations for the program:

• Over 75% of the committee voted to remove the 19-day lockout period.

• Most advisory committee members discussed allowing patients to have access to home pregnancy testing for iPLEDGE after the public health emergency and nearly all support non-CLIA pregnancy tests for in-office testing.  

• 73% of the committee members voted to remove the monthly attestation requirement to every 4 months or at the time of enrollment, for patients who cannot become pregnant.

• Many members were in support of Isotretinoin Products Manufacturers Group (IPMG) having physician and stakeholder representation, including regular meetings with the manufacturers.

Prior to the meeting, the FDA approved several minor changes the Academy has advocated for since the transition to the new platform, such as reinstating the calendar feature. AADA also urged the IPMG to implement these changes immediately.

AADA iPLEDGE Workgroup leaders, Ilona Frieden, MD, FAAD, and John Barbieri, MD, FAAD, presented oral testimony outlining Academy members’ concerns and recommendations to the program, and AADA submitted written comments. Additionally, 286 member dermatologists submitted comments to the FDA through AADA’s member action alert center. The AADA’s entire iPLEDGE Workgroup has been relentlessly advocating over the past several years to fix iPLEDGE, and their efforts only intensified following the disastrous rollout of the new iPLEDGE REMS platform in late 2021. See the AADA's written testimony (PDF).

WHAT’S NEXT: Although FDA is not legally required to follow advisory committee members’ recommendations, FDA generally accepts the committee’s proposed changes. In the coming weeks, the AADA will follow up with the FDA and urge them to accept these recommendations.

Jan. 19, 2023

Success! FDA to hold joint committee meeting on iPLEDGE changes

As a direct result of the AADA’s persistent advocacy efforts to fix the iPLEDGE program, the FDA announced it will host a two-day joint committee meeting with the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee on March 28 – 29, 2023, to address upcoming changes to the iPLEDGE REMS. The AADA will participate in the meeting and once again provide its recommendations to improve the iPLEDGE program to the FDA. 

Dec. 20, 2022

Win for iPLEDGE and REMS reform

Language that the AADA championed will require the FDA to provide a public comment period regarding patient access and provider administration when a proposed modification to an approved risk evaluation and mitigation strategy (REMS) is made. Following the iPLEDGE crisis in 2021 and early 2022, the AADA partnered with the American Psychiatric Association to work with Reps. John Joyce, MD, FAAD (R-PA), Doris Matsui (D-CA), and Morgan Griffith (R-VA) to develop legislative language with the goal of protecting against such a crisis occurring in the future.

Oct. 11, 2022

AADA participates in FDA-sponsored REMS Workshop

AADA iPLEDGE Workgroup Chair Ilona Frieden, MD, FAAD, participated on a panel discussion, Challenges and Opportunities for Risk Evaluation and Mitigation Strategies (REMS) Integration, Innovation, and Modernization, on Oct. 11, 2022. The workshop was jointly hosted by the FDA and Duke-Margolis Center for Health Policy and was intended to solicit feedback from key stakeholders on the REMS integration prototype and FDA’s ongoing efforts to modernize REMS.

Dr. Frieden participated in the prescriber panel moderated by former FDA Commissioner and CMS Administrator Mark McClellan, MD, PhD. During the discussion, Dr. Frieden shared the many challenges of the iPLEDGE program, especially since the relaunch that occurred in late 2021 and highlighted that the program is still not fixed. Dr. Frieden also provided examples of the logistical burdens of the iPLEDGE REMS program and made recommendations for improvements and the need for data to better develop program requirements.

This workshop was one of the many ways that the AADA is addressing member concerns and frustrations with the iPLEDGE REMS Program. The AADA’s iPLEDGE Workgroup will continue to advocate for needed improvements to the iPLEDGE REMS program with the FDA and iPLEDGE sponsors.

July 19, 2022

AADA keeps pressure on IPMG to fix iPLEDGE REMS program

On Monday, July 18, leaders of the AADA’s iPLEDGE Workgroup again met with representatives from the Isotretinoin Product Manufacturers (IPMG) and the FDA to advocate for improvements to the iPLEDGE Program.

The purpose of the meeting was to follow-up on the status of the planned updates that were shared during the previous meeting held on May 18, including reinstating the calendar functionality, enhanced enrollment process, and general prescriber and designee updates. The IPMG again shared that the upgrades could take six months to a year to implement, noting the FDA must approve these changes first, after which their vendor will need time to implement within the iPLEDGE site. AADA again pressed IPMG to expedite the implementation of these changes.

Additionally, the AADA took the opportunity to repeat calls for the IPMG to address issues that have plagued the program for years, including:

• Removing the monthly physician attestation requirements from iPLEDGE REMS for patients who cannot become pregnant.

• Removing the 19-day “lockout” period if a patient misses an initial window period.

While IPMG showed more willingness to addressing AADA’s concerns to the program for patients who cannot get pregnant, AADA will continue to pressure IPMG on both issues, so all patients have better access to needed treatments. Finally, the AADA again requested a multi-stakeholder meeting with IPMG, patients, and physicians, among others, to work together on a long-term fix to the program. Unfortunately, the IPMG declined this request, and the AADA plans to make this request directly with the FDA.

June 8, 2022

House passes iPLEDGE reforms

On June 8, the House of Representatives overwhelmingly passed the Food and Drug Amendments of 2022, which includes language sought by the AADA that addresses concerns regarding the rollout of the iPLEDGE REMS platform.

The bill would reauthorize brand, generic, and biosimilar prescription drug and medical device user fees. The REMS-related language was included in the bill by Rep. John Joyce, MD (R-PA), a dermatologist, with the bipartisan support of Reps. Doris Matsui (D-CA) and Morgan Griffith (R-VA). The REMS-related provisions would require that:

• The FDA seek public comment on factors the Secretary of Health and Human Services must consider when reviewing requests from REMS sponsors to change third-party vendors helping to manage programs like iPLEDGE, including the impact on patients and on physician prescribing and administration.

• The GAO assemble a report by 2026 on the scope, impact, and resolution of REMS program vendor changes.

The Senate Health, Education, Labor & Pensions (HELP) Committee is expected to consider its FDA user fee bill later this month. The AADA is working to ensure that the Senate bill retains the REMS language and it remains in the final package.

June 3, 2022 

AADA counters IPMG objections to iPLEDGE improvements

On June 3, 2022, AADA Government Affairs and Health Policy Council Chair Bruce Brod, MD, FAAD, sent a letter to the Isotretinoin Product Manufacturer Group (IPMG) to address IPMG’s reservations with AADA’s recommendations for improvements to iPLEDGE that were shared during a May 18 meeting between the AADA, IPMG, and FDA.

As previously reported, IPMG shared plans to address some of the AADA’s concerns, including reinstating the calendar functionality, an enhanced enrollment process, and general prescriber and designee updates, but was unable to provide a timeline for implementation, stating such improvements could take up to six months due to FDA review. In his letter, Dr. Brod again urged the IPMG to make these changes as quickly possible and questioned the need for FDA review since these features previously existed but disappeared when the program migrated to the new platform.

During the meeting, AADA again urged IPMG to:

• Remove the monthly physician attestation requirements for patients who cannot become pregnant.

• Remove the 19-day “lockout” period if a patient misses an initial window period.

The IPMG shared its concerns that removing the monthly physician attestation requirements for patients who cannot become pregnant would increase the potential for drug diversion and additional changes would further upset users. In his letter, Dr. Brod responded that there is no evidence supporting these concerns and offered additional suggestions and comments.

The IPMG expressed reservations with AADA’s recommendation to remove the 19-day “lockout” period when patients miss the initial window period to pick up the medication. They shared that the rationale for the 19-day “lockout” policy is based on a standardized 28-day ovulation cycle and the need to avoid starting the drug in the “fertile period” in the second month. The AADA argued that such concerns are also unfounded and provided alternatives that would more effectively achieve the appropriate balance of avoiding fetal exposure to isotretinoin and ensuring patients have safe access to the medication.

Dr. Brod again called on IPMG to increase transparency and facilitate multi-stakeholder meetings between prescribers, IPMG, and the FDA.

May 25, 2022

AADA renews calls for iPLEDGE improvements with IPMG, FDA

Leaders of the AADA iPLEDGE workgroup met with the Isotretinoin Product Manufacturer Group (IPMG) and the FDA on May 18, 2022, to renew demands for changes addressing issues that have plagued the program for years. During the meeting, AADA members outlined how the program’s approach to preventing isotretinoin exposed pregnancy is illogical; impedes access to needed treatment, especially in populations that already experience health care disparities; and exacerbates physician shortage issues by necessitating additional appointments.

The AADA again urged IPMG to:

• Remove the monthly physician attestation requirements from iPLEDGE REMS for patients who cannot become pregnant.

• Remove the 19-day “lockout” period if a patient misses an initial window period.

• Increase transparency and collaboration to facilitate needed improvements.

Throughout the crisis and after, the Academy has also advocated for improvements to the platform, including restoring key features that were removed when the program migrated. At the meeting IPMG shared plans that address these concerns, including reinstating the calendar functionality, enhanced enrollment process, and general prescriber and designee updates. However, IPMG was not able to provide a timetable for implementation, noting the FDA must approve these changes first, which could take up to six months after submission, after which their vendor will need time to implement within the iPLEDGE site. AADA urged IPMG and FDA to expedite this process.

Additionally, advocacy by the AADA with Congress has resulted in language addressing reforms to the administration of REMS programs (including iPLEDGE) in draft legislation that would reauthorize drug and medical device user fees. The language would require public input on REMS program changes in the future. The AADA has noted that lack of input from physicians and patients before implementation of the changes last year contributed significantly to the crisis that ensued. The bill also include language requiring the Government Accountability Office to investigate the scope, impact, and resolution of REMS program vendor changes.

Jan. 26, 2022 — Message from Bruce A. Brod, MD, MHCI, FAAD

iPLEDGE advocacy brings new opportunities for long-term change

Dear Colleagues:

Today, we met with the FDA, the Isotretinoin Product Manufacturers Group (IPMG), pharmacists, and other relevant stakeholders to continue our discussions on the significant issues with the iPLEDGE program.

During this joint stakeholder meeting, the IPMG shared that some issues with the iPLEDGE program have been addressed, but there is still ongoing improvement. Additionally, the FDA was amenable to reevaluating the current program and expressed interest in long-term fixes to the iPLEDGE system. The AADA is encouraged by this and has requested regularly scheduled joint meetings to hold the IPMG and the FDA accountable for ensuring that the iPLEDGE program effectively meets its stated goals of preventing fetal exposure without causing unintended harm to patients.

Though the IPMG has reported recent steps to make improvements in the system, we all agree that is not enough. Our asks for a long-term fix still stand, which include:

1. Remove from iPLEDGE REMS the monthly physician attestation requirements for patients who cannot become pregnant.

2. Remove the 19-day “lockout” period if a patient misses an initial window period.

3. Increase transparency and improve inclusion of stakeholders, including dermatologists to address the current crisis and to prevent future issues with the program.

Share your feedback: If you are continuing to experience issues with the iPLEDGE platform, please fill out this form to help inform ongoing advocacy for short- and long-term solutions.

Our advocacy continues, and we will keep you informed with new updates. Please find below a holistic view of the Academy’s efforts to resolve these immediate concerns which include:

• Regular meetings with the FDA, IPMG, pharmacists, and other relevant stakeholders.

• Direct outreach to the isotretinoin manufacturers.

• Calling on key congressional offices to 1) reach out to the FDA on our behalf and 2) develop strategies to continue the pressure.

• Responding to media requests seeking dermatologists' perspective and the plight of the patients being impacted.

• Coalition building which includes bolstering our partnerships with the National Association of Chain Drug Stores and the American Psychiatric Association, whose members have experienced a remarkably similar breakdown in the REMS program for clozapine.

We remain steadfast in our asks to stabilize the iPLEDGE program, requesting physician input for future improvements, maintaining safe access to isotretinoin, and identifying agreeable solutions with all stakeholders involved.

Lastly, please refer to the iPLEDGE guidance in the Academy’s Practice Management Center for the latest information.

Sincerely,

Bruce Brod, MD, MHCI, FAAD
Chair, AADA Council on Government Affairs and Health Policy

Jan. 11, 2022 — Message from Bruce A. Brod, MD, MHCI, FAAD

iPLEDGE advocacy continues with Congressional outreach; coalition building

Dear Colleagues:

Like many of you, my focus has been on my severe acne patients who cannot gain or maintain access to the iPLEDGE Risk Evaluation and Mitigation Strategies (REMS) system and their medication. My colleagues on the iPLEDGE workgroup and I have been working with our AADA staff team around the clock. The AADA is acutely aware of this ongoing, paralyzing, and problematic issue and continues to fight on behalf of our specialty and patients. Unfortunately, we’ve been met with major obstacles every step of the way.

In December, we have participated in:

• Two FDA listening sessions, one of which the Assistant Secretary of Health, Admiral Rachel Levine, attended and pressured all stakeholders to work together to find a solution.

• Three meetings with pharmacy representatives, including Walgreens and CVS working towards finding a solution that works for all stakeholders.

• Two meetings with the Isotretinoin Product Manufacturers Group (IPMG), where we proposed several solutions to improve access and directly pleaded for more transparency and dermatologists’ input into future enhancements; the IPMG did not provide an update on how the FDA perceived our proposals or any efforts to assure us that, what we believed to be reasonable solutions, were being considered in the immediate future.

Additionally, we’ve been working with the National Association of Chain Drug Stores, have conferred with them, and sent a joint letter to the IPMG, where we proposed workaround solutions to address the greatest obstacles in getting patients their medication.

Unfortunately, those recommendations have not come to fruition and no explanation has been given as to why they have not been implemented. Like you all, I, and the other members of the iPLEDGE Workgroup, are angered by the lack of transparency, accountability, and action from stakeholders responsible for addressing our issues. However, we continue to press forward, and this remains the Academy’s top advocacy priority today.

As the fight continues, we are partnering with the American Psychiatric Association, which has seen strikingly similar issues with their REMS program related to clozapine, a potentially lifesaving medication for patients living with schizophrenia who have not responded to other medications. We are working on a joint letter to Congress detailing consistent concerns with both REMS programs and recommending that they both be suspended immediately and undergo thorough reviews.

Additionally, we continue to work to bring Congressional pressure and have had confirmation that member offices from the House Energy and Commerce Committee and the Senate Health Education, Labor and Pension Committee have reached out to the FDA on our behalf. In the meantime, we are constantly requesting greater transparency and communication from the IPMG and FDA as we need to be included in their daily meetings and have a direct contact to the decision makers.

As for updates to the iPLEDGE system, IPMG is reporting that the platform has a new functionality (first implemented on Jan. 9, 2022) allowing prescribers and designees to send a direct activation link to their patients. Based on member feedback of this feature, it is believed to be a “self-service” option to better assist your patients requesting access to the system.

We were also provided this email address – customersupport@iPledgeRemsSupport.com – for physicians to use to help triage access problems. The IPMG assured us that there is a dedicated team behind the email address that is working directly with the Contact Center to resolve the issues. We have tested this with a group of physicians and their colleagues and there has been some progress through this new tactic.

While this represents a step in the right direction, our advocacy efforts continue for short- and long-term changes to the iPLEDGE REMS program including including 1) reduced attestation requirements for those who cannot get pregnant and 2) amnesty to those who are locked out through no fault of their own because of their inability to attest to non-pregnancy status.

The Academy has several resources to assist you and your patients in gaining access to iPLEDGE system including:

• An archive of all the messages we shared with membership.

• The latest guidance on how to navigate the iPLEDGE system should you acquire access to it.

• An option for patients to submit their iPLEDGE story to us to assist in our advocacy.

Please know that the Academy remains steadfast in its approach to find relief from this arduous system that is impeding patient care.

Sincerely,

Bruce Brod, MD, MHCI, FAAD
Chair, AADA Council on Government Affairs and Health Policy

Jan. 3, 2022 — Message from Bruce A. Brod, MD, MHCI, FAAD

AADA meets with IPMG, calls for multi-pronged solution

Dear Colleagues:

Throughout the holidays, the American Academy of Dermatology Association (AADA) has continued to pressure the iPLEDGE Product Manufacturers Group (IPMG) to halt the program, fix its platform, or find reasonable workarounds to restore patient access to isotretinoin. On December 30, members of the AADA iPLEDGE Workgroup were invited to meet with members of the IPMG, who were seeking feedback from the AADA on a possible workaround that would allow physicians who are unable to access the system to fax a form with a universal Risk Management Authorization (RMA) in lieu of going through the iPLEDGE platform. Those who have managed to successfully access the system would continue to do so.

This solution was reflective of some of the feedback the AADA has shared with the FDA and IPMG; however, as we noted during the meeting and in subsequent communication to the FDA and IPMG, this will not work for all scenarios, and it is critical to consider multiple pathways toward a solution. In addition to our feedback on IPMG’s proposal, we put forward the following suggested solutions:

• Instead of requiring that patients who cannot get pregnant be qualified monthly to receive isotretinoin, require qualification only at the time of enrollment and once yearly thereafter.

• The removal of patient attestation requirements, which would allow patients who are unable to access the system to receive isotretinoin, once qualified by their prescriber.

• Amnesty for those who missed window periods and were inappropriately put back into the 30-day waiting period.

We are also calling for increased transparency from the IPMG regarding the status of iPLEDGE, including call wait times, which we understand anecdotally remain high, and how many prescriptions are currently being filled as compared to prior to December 13. We also called for more direct discussion among stakeholders to expedite delivery of a solution for patients, physicians, and pharmacists and as we press for long term reform of the iPLEDGE risk evaluation and management strategy.

Additionally, we are working with media outlets to share information on this issue, including Medscape, Dermatology Times, Fox5 DC, Bloomberg Law, and TODAY.

As our advocacy on this issue continues, we would like to share more information with IPMG and FDA about how this situation is impacting patients. Please share this link with your patients and ask them if they would be willing to share their story with us at staging.aad.org/iPLEDGEstories. No individually identifiable information will be collected or shared with stakeholders.

Sincerely,

Bruce Brod, MD, MHCI, FAAD
Chair, AADA Council on Government Affairs and Health Policy

Dec. 23, 2021 — Message from Bruce A. Brod, MD, MHCI, FAAD

AADA engages Congress, works with pharmacists on solutions

Dear Colleagues:

As the iPLEDGE debacle grinds on, we maintain our pressure on the FDA demanding a temporary suspension and urgent fix, while also seeking support from Congress and working to proactively identify actionable solutions that restore isotretinoin access while upholding the goal of the REMS program to prevent pregnancy exposure.

The AADA is in frequent contact with Democratic and Republican staff on House Energy & Commerce and Senate HELP Committees, and we confirmed yesterday that, in response to our requests, Energy & Commerce Committee staff have reached out to the FDA regarding AADA's demand for immediate relief to physicians and patients. AADA member Rep. John Joyce, MD, FAAD, (PA-13), and his office has been engaging Energy and Commerce staff and the FDA on the matter as part of his ongoing advocacy in Congress.

In the absence of any definitive action to date from FDA or the iPLEDGE sponsors, yesterday the AADA also convened a call with the National Association of Chain Drug Stores and some of its member organizations to identify possible workarounds to the dysfunctional platform. In addition to sharing our solutions, the AADA is asking the FDA for regular meetings facilitated by the agency. In making this request, we note that the iPLEDGE Manufacturers Group (IMPG) has not shown a willingness to meet with the AADA or pharmacy stakeholders. AADA and pharmacy stakeholders have made multiple attempts to meet and collaborate with the IPMG, however they declined. The group has also refused to share contact information and their organizational structure remains opaque.

As we continue our efforts, it’s important that those affected by this transition share their experience and the impact of delayed and disrupted care on patients. We encourage you to write to the FDA at druginfo@fda.hhs.gov and to the IPMG at iPLEDGE@rems-pmo.com and share your stories, with a particular emphasis on problems and obstacles that have continued in the past few days. We also ask you to share this information with your patients and encourage them to reach out and share their experiences as well.

Sincerely,

Bruce Brod, MD, MHCI, FAAD
Chair, AADA Council on Government Affairs and Health Policy

Dec. 21, 2021 — Message from Bruce A. Brod, MD, MHCI, FAAD

iPLEDGE fight continues as our frustration grows

Dear Colleagues:

After a week of continued malfunction of the new iPLEDGE platform, many patients are experiencing significant disruption in treatment, and the frustration of patients and prescribers is mounting. While some have succeeded in accessing the system, once on the web site they find a platform that is difficult to use and dysfunctional in many ways. Further, the call center continues to be essentially unavailable to those seeking help. This is the message we have repeatedly shared with the FDA and iPLEDGE sponsors as this failed roll-out continues.

Since we last gave you an update, the AADA has been very active behind the scenes. We have represented the point-of-view of prescribers and patients at two meetings called by the FDA within the past week to try to address the problems we are facing. These meetings have included designees of the isotretinoin manufacturers as well as organizations representing pharmacies.

While we are very disappointed with the slow pace of change, we appreciate that the FDA is engaging in a serious way, and we continue to press our urgent case with all stakeholders and engage with potential allies to find a solution for AADA members. In our most recent communication with the FDA we asked the agency to come together with us and other stakeholders in the next 24 hours to address the problem, and we reiterated our call for a temporary suspension to the program. We also suggested additional approaches to restore access to treatment and offered to continue to meet as often as is needed with key stakeholders to urgently resolve this issue.

In addition, we have reached out to representatives of national chains as well as independent pharmacy groups to proactively seek mutually agreed upon recommendations that would restore treatment to patients and ensure the objective of the REMS program, preventing fetal exposures, is upheld. A meeting with the National Association of Chain Drug stores is scheduled for tomorrow.

I know everyone in the dermatology community, including myself and other members of the AADA iPLEDGE Workgroup, are deeply frustrated and worried for our patients. An end to the immediate crisis so that we can turn to addressing the longstanding issues with iPLEDGE is the sole focus of the workgroup. We will continue to keep you updated on our actions and developments as we hear them.

Sincerely,

Bruce Brod, MD, MHCI, FAAD
Chair, AADA Council on Government Affairs and Health Policy

Dec. 15, 2021 — Breaking News

AADA to meet with leaders of HHS and FDA

Due to the Academy’s tireless outreach regarding the unacceptable situation with iPLEDGE, the FDA has convened an emergency meeting with AADA representatives and Admiral Rachel L. Levine, MD, assistant secretary for health; and Patrizia Cavazzoni, MD, director of the FDA Center for Drug Evaluation and Research, on Thursday, Dec. 16.*

The Academy also received an update yesterday from representatives with Syneos Health, who acknowledged the AADA’s concerns and reported they are actively working with their service providers to resolve website issues, hold times, and access to the call center, although a timeline was not provided.

At the Thursday meeting, AADA representatives will underscore the urgent situation faced by dermatology patients unable to secure their prescriptions, repeat calls for a halt to the program so that care can be restored without further delay and disruption, and outline plans for how dermatologists will maintain patient safety while the program is suspended.

AADA is encouraging members to continue to share experiences leading up to the Thursday meeting with the FDA via our grassroots Take Action Center.

* The date of the meeting was previously reported incorrectly. The meeting is on Dec. 16. Also, previous communication incorrectly stated that Syneos would participate in this meeting.

Dec. 14, 2021 — President's Message

iPLEDGE issues are an unacceptable disruption to patient care

The Academy is aware of the issues faced by dermatologists and patients attempting to use the new iPLEDGE platform beginning yesterday; and leadership agrees that this is not acceptable for our patients or our practices. We have contacted the FDA and Syneos to urgently communicate that the new platform rollout has been a nightmare for dermatology practices and patients; and it has created an unacceptable disruption in patient care. In addition, we are reaching out to congressional committees overseeing the FDA asking them to take action and have contacted health policy reporters to shine a light on the crisis.

Over the last several weeks we have repeatedly warned the FDA and Syneos that the proposed changes did not reflect clinical practice and would impede patient care; and we asked for a halt to the program until our concerns could be addressed. We were told “no,” with the explanation that suspending the iPLEDGE program would not, from FDA’s perspective, provide the safeguards that are necessary to prevent embryofetal exposure. They also assured us that the iPLEDGE administrator was taking steps to address many of our concerns before launch. Clearly, those steps have not been effective.

The Academy appreciates all members’ messages via our Member Resource Center. We will use those messages and shared experiences as we renew our calls for an immediate suspension to the program and continue efforts to urgently seek solutions to the current crisis as well as to longstanding issues with the program.

It’s also critical that the FDA hear the collective voice of dermatologists about the impact on your patients. Please look for an email link later today and share your experience via the Academy’s grassroots Take Action Center.

Kenneth J. Tomecki, MD, FAAD
President, American Academy of Dermatology Association

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