Become an Advocate

At the International Pemphigus & Pemphigoid Foundation (IPPF), we advocate on behalf of people affected by pemphigus and pemphigoid (P/P) to affect positive change on many important issues that include:

  • Ensuring access to high quality health care for patients coping with a diagnosis of P/P;
  • Improving patients’ protections in our current healthcare system;
  • Increasing federal funding to advance medical research;
  • Providing federal funding for disease awareness and education

The IPPF has led the way in voicing the needs of the pemphigus and pemphigoid community. We work closely with our like-minded advocacy partners on the federal and state level to inspire policies supportive of the needs of P/P and other rare disease patients and their families.

Together, we can drive favorable policies by reaching out to legislators and decision-makers to inform them of our public policy concerns, bring attention to the disease and inform the public about P/P.

Advocacy partnerships

American Academy of Dermatology (AAD)

The American Academy of Dermatology was founded in 1938. It is the largest, most influential and representative dermatology group in the United States. With a membership of more than 19,000, it represents virtually all practicing dermatologists in the United States, as well as a growing number of international dermatologists. Additionally, it has an active advocacy branch to its organization and provides physicians and their patients up-to-date information on issues that may affect them. The American Academy of Dermatology Association established principles to guide physician leadership in taking policy positions and advocating for health system reform. At the root of these guiding principles is the need to preserve the patient-physician relationship.

RDLA

Rare Disease Legislative Advocates is a program of the EveryLife Foundation for Rare Diseases designed to support the advocacy of all rare disease patients and organizations. By growing the patient advocacy community and working collectively, we can amplify our many voices to ensure that rare disease patients are heard in state and federal government. RDLA provides free resources for successful grassroots advocacy.

National Organization for Rare Disorders (NORD)

The National Organization for Rare Disorders (NORD), a nonprofit organization, is a unique federation of voluntary health organizations dedicated to helping people with rare “orphan” diseases and assisting the organizations that serve them. NORD is committed to the identification, treatment, and cure of rare disorders through programs of education, advocacy, research, and service.

International Alliance for Dermatological Patient Organizations (IADPO)

The International Alliance of Dermatology Patient Organizations (IADPO) – also known as GlobalSkin – is a unique global alliance, committed to improving the lives of patients worldwide. We nurture relationships with members, partners and all involved in healthcare – building dialogue with decision-makers around the globe to promote patient-centric healthcare. GlobalSkin’s work is founded on three pillars: research, advocacy and support.

Haystack Project

The Haystack Project is committed to the Rare and Ultra Rare Disease Community. It brings together Innovators, Patients and Caregivers to educate and advocate for policies that recognize the unique circumstances of extremely rare conditions and treatments.

Global Genes

Global Genes is a global community changing the way the world tackles rare disease. Our partners include nonprofit, government, academic, research, service and industry organizations that believe collaboration is the key to positive change.

Advocacy Resources

Are you experiencing healthcare challenges with P/P and do you want to make your voice heard by expressing your thoughts to your elected officials? Do you want to bring awareness to P/P by sharing your story and information about your disease?

The IPPF invites you to become empowered and utilize a variety of advocacy resources provided here that can help you gain attention and support for the issues that are most important to you and the IPPF community.

Helpful Resources:

Elevating Awareness of the Pressing Needs of the Pemphigus Community – This white paper focuses on the urgent needs of pemphigus patients that were defined at our Patient Forum in October, 2020.

Track Legislation – Learn about and track information about legislative issues.

RDLA Advocacy Tools – Advocacy tools designed to help rare disease patients, parents, caregivers and other affected parties learn the basics of legislative advocacy.

Global Genes Resource Hub – Extensive information center for patients and advocates.

NORD Advocacy – Analyses of legislative and regulatory activity.

Haystack Project Resources – Letters, presentations and reports on policy issues.

Sign On Letters

January 2021:

  • Sent a comment letter to United Healthcare regarding their  intentions to move Remicade from preferred to non- preferred coverage in February 2021. This abrupt change by the plan could be disruptive to stable patients and their care, and undermines the treatment regimen set by patients and their prescriber.
  • Joined sign on letter to the Biden administration supporting the appointment of Dr. Janet Woodcock as Acting Commissioner of the FDA.

February 2021:

  • Signed group letter urging FDA to commit to increased efficiency of generic approvals, and greater attention to the next generation of generic drugs – complex generics – that, by their nature, require a more intensive review.
  • Sign on to express strong support for the provision in the COVID relief reconciliation bill (section 3108) adopted by the House Energy and Commerce Committee that will provide life-sustaining support, during this deadly pandemic, for people with disabilities, older adults, and individuals, predominantly low-income women of color, who make up part of the direct care workforce.  Modeled on the COVID HCBS Relief Act of 2021 (S. 151/H.R. 525), the bill would provide additional funding for Medicaid Home and Community Based Services (HCBS). This funding must be included in the final COVID relief package.
  • Sent letter to California Senate Committee on Health to urge their  swift consideration of SB 247 to help enable the creation of a California Rare Disease Advisory Council.
  • As Congress works to draft the Labor, Health and Human Services, Education and Related Agencies (Labor-HHS) appropriations legislation for fiscal year (FY) 2022, the [XXX] undersigned organizations request $3.75 billion for the Centers for Disease Control and Prevention’s National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) in its mission to help people and communities prevent chronic diseases and promote health and wellness for all.
  • Request that Congress fund the National Institute of Dental and Craniofacial Research (NIDCR) at $520 million and the National Institutes of Health at $46.111 billion. Funding at these recommended levels will allow for the entities’ base budgets to keep pace with the biomedical research and development price index (BRDPI) and provide meaningful growth of 5%. 

March 2021:

  • Signed on to a letter to the Biden Administration asking for support for the bipartisan RISE Act, led by Representatives Diana DeGette (D-CO), Fred Upton (R-MI), Eddie Bernice Johnson (D-TX), Anna Eshoo (D-CA) and Anthony Gonzalez (R-OH) in the House and Senators Edward J. Markey (D-MA), Thom Tillis (R-NC), Susan Collins (R-ME), and Gary Peters (D-MI) in the Senate, would provide $25 billion to help restore our nation’s research capacity to its pre-pandemic strength, prevent setbacks against the formidable challenges our nation faces, and further the goal of a robust, diverse, and inclusive STEM workforce. 
  • Sent letter to Congressional leadership to express our support for the Ensuring Lasting Smiles Act (ELSA). This bipartisan legislation will have a direct impact on patients and will eliminate the existing burdens that prevent access to necessary diagnosis and treatment for those with congenital anomalies or birth defects. 

January 2020

  • Signed on to a letter that would support the requirement that taxpayer-funded research be made available immediately and freely – finally eliminating the current 12-month waiting period for the public to gain access to the outputs of scientific research, including data and articles.
  • Signed on to a letter to Congress urging them to enact policies that would help
    ensure prompt and equitable access to transformative, potentially curative treatments, such as gene therapy.
  • The IPPF signed on to a letter to express our support for HR 1379, the Ensuring Lasting Smiles Act (ELSA). This bill was part of the Health, Employment, Labor, and Pensions Subcommittee’s Jan. 28 hearing; “Expecting More: Addressing America’s Maternal and Infant Health Crisis”.
  • Signed on to letter to HHS Secretary Alex Azar to act immediately to restart the activities of the ACHDNC so it can continue its critically important work to improve newborn screening and save babies’ lives.

February 2020

  • Signed onto letter to the Center for Medicare Services (CMS) opposing the proposed rule that would expressly allow insurance plans to exclude drug manufacturer copay assistance from counting towards patients’ annual limitation on cost sharing.

March 2020

  • Letter sent to Congress and the Administration to take action to address the following issues during the Coronavirus (Covid-19) pandemic :
    • Require all payers to allow for provision of an emergency supply of medications and supplies by relaxing restrictions on timing of refills and amounts, to at least the CDC-recommended extra 30-day supply and up to a 90-day supply to reduce returns to the pharmacy; Ensure that these protections extend to medications that are controlled substances indicated for and used to treat epilepsy, mental illnesses, cancer and other serious medical conditions, as well as injectables; Require all payers to waive prior authorization and utilization management requirements; Require flexibility regarding use of mail order pharmacies, including out of state mail order pharmacies; and other home delivery methods; Require payers to relax requirements for in-person visits for refills, including allowing visits through tele-health; Require all payers to establish policies to assist patients with cost-sharing related to their emergency supply or allow for delayed payment of out-of-pocket costs for emergency supplies; Increase FDA monitoring and reporting of shortages to ensure consistent supply, especially existing medications approved to treat chronic conditions that may be under study or used to treat COVID-19.
  • Help draft a letter to the Trump Administration, requesting that he not take any action that would destabilize the health care supply chain during the Covid-19 crisis.

April 2020

  • Sent letter urging Congress to expand eligibility for the paid family and medical leave program to include individuals determined by the Centers for Disease Control and Prevention (CDC) to be at high risk for adverse complications from COVID-19 and working members of their households

June 2020

  • Signed letter in support of the Part B Access to Seniors and Physicians (ASP) Coalition’s mission to preserve patient access to Medicare Part B covered services. The IPPF is deeply concerned with the current inaccessibility to Part B Medicare-covered drugs for beneficiaries enrolled in Medicare Advantage (MA). MA plans have been using prior authorization restrictions as a barrier to timely delivery of essential Medicare Part B covered drugs to beneficiaries, putting the health of these patients at risk. MA plans are required by law to cover the same services as fee-for-service (FFS) Medicare – plans should not be permitted to use prior authorization to circumvent this requirement.
  • Signed on to a letter on behalf of the patients we represent, stating that we strongly oppose recent policy changes in the 2021 Notice of Benefit and Payment Parameters (NBPP) that would allow the exclusion of manufacturer cost-sharing assistance from counting towards patients’ out-of-pocket maximums in the commercial market. This policy will prevent patients from accessing the medications they depend upon and create unnecessary barriers to maintaining effective treatment plans, especially during the global Covid-19 pandemic.

July 2020

  • Sent sign-on letter urging Congressional leadership, as part of the next Coronavirus (COVID-19) legislation, to task the CDC with working with stakeholders to develop a recommendation to ensure the needs of immunocompromised Americans are adequately addressed.
  • Signed letter that calls on Congress to address rising out-of-pocket costs in Medicare Part D in the upcoming COVID-19 relief package.
  • Signed letter intended to demonstrate a strong show of support to CMS that their latest attempt to undermine copay coupon assistance is not acceptable to patient advocates and others representing vulnerable persons who depend on these programs for their medicines, their health and well-being.
  • Sent letter to urge the Congress to prioritize robust federal funding for the critical testing needed to reopen the country. Swift action is needed to ensure that every American, including essential workers, frontline healthcare providers and those at disproportionate risk for COVID-19 have access to vital COVID-19 testing, whether for diagnostic, occupational, return-to-school, public health or surveillance purposes.

August 2020

  • Sent sign-on letter urging Congressional leadership, urge you to work toward the enactment of the fiscal year 2021 Defense Appropriations Act, to ensure that the Defense Health Research Programs, including the Congressionally Directed Medical Research Programs (CDMRP), are fully funded in fiscal year 2021.
  • Sent letter to Congressional leadership urging them to rescind the current ban on the use of copay cards in the Medicare Part D program at least through the current Novel Coronavirus (COVID-19) pandemic.

September 2020

  • Open letter to federal healthcare agency leaders asking them to keep their focus on the science and avoid the appearance of political influence on decision-making. 
  • Helped draft a comment letter to CMS on their annual proposal on doctors’ payments in the office setting of care.

October 2020

  • As a supporter of the Ensuring Lasting Smiles Act (HR 1379/S 560), legislation to require health insurance coverage for treatment of patients with congenital anomalies. We are pleased to report the House Energy and Commerce Committee passed the bill last month. The House Education and Labor Committee and House Ways and Means Committee share jurisdiction on the bill, and we have heard the Education and Labor Committee does not want to waive its jurisdiction. We signed on to a letter asking committee leaders to either mark up the bill or waive jurisdiction so we can get the bill to the House floor as quickly as possible given the limited amount of days left in the 116th Congress. 
  • The IPPF signed on to two letters that AARDA received from Aimed Alliance addressed to WEA Trust and United Healthcare regarding their recent communication to health care providers detailing provider and medical practice protocols for copay accumulator programs.  These programs will negatively impact patients’ ability to access their medications, an issue that we have recognized as vital for patients with autoimmune diseases.

November 2020 

  • Signed letter to HHS Secretary, Alex Azar, recommending that HHS provide guidance to state Medicaid programs and Medicaid Managed Organizations (MCOs) clarifying that, during the Public Health Emergency, all FDA-approved treatments for COVID, including those approved under an Emergency Use Authorization (EUA,) must be covered for Medicaid beneficiaries without delay and without prior authorization (PA) requirements. HHS should also clarify that this requirement applies to all therapies – whether inpatient, outpatient, or pharmacy. Finally, if existing contracts with state Medicaid managed care organizations prevent the waiver of PA requirements, states should carve out COVID-19 treatments into the fee-for-service (FFS) benefit. 

December 2020 

  • Signed letter with ASP along with The Part B Access for Seniors and Physicians (ASP) Coalition calling on Congressional leadership to abandon the MFN Model and focus on patient-centered reforms to protect provider-patient relationships and the high-quality care that our country has consistently been able to offer.
  • Signed onto the Friends of NIDCR letter urging congressional appropriators to provide at least the Senate level of $493.234 million for the National Institute of Dental and Craniofacial Research as well as supplemental funding for the National Institutes of Health in fiscal year 2021 spending legislation.

January 2019

  • Signed on to AARDA’s comment letter responding to the Medicare Advantage and Part D proposed rule.

February 2019

  • Signed on to a letter of support for the Ensuring Lasting Smiles Act (ELSA). This link provides an overview for you about the efforts regarding the Ensuring Lasting Smiles Acthttps://www.nfed.org/get-involved/advocate/ensuring-lasting-smiles-act/
  • Sign-on to draft comments by I Am Essential for the proposed 2020 Notice of Benefit and Payment Parameter. The letter outlines the impact the proposed changes would have on patient access to and affordability of prescription drugs.

March 2019

  • Signed on to a letter with AARDA recommending that Congress allocate $8.0 million in fiscal year 2020 for a stand-alone, dedicated autoimmune disease program in the Department of Defense Congressionally Medical research Program (DoD CDMRP). The CDMRP is located in the US Army Medical Research and Materiel Command to support peer-reviewed medical research programs (PRMRP) to identify and select military health-related research of exceptional scientific merit across 50 or so priority topic areas, including arthritis, diabetes, epilepsy, inflammatory bowel disease, lupus, multiple sclerosis, scleroderma, and other autoimmune diseases.

May 2019

  • Signed a letter in support of Medicare coverage for medically-necessary oral/dental health therapies along with 92 other signatories sponsored by International & American Associations for Dental Research.
  • Requested Congressional support for the critical and highly successful defense health research
    programs funded through the Congressionally Directed Medical Research Programs (CDMRP) at
    the Department of Defense (DoD).

July 2019

  • Sent to Chairman Grassley, Ranking Member Wyden, Leader McConnell, Minority Leader Schumer, and the entire Senate Finance Committee a letter Urging senate leadership to maintain Medicare Part B protections.
  • Sent letter to Administrator Seema Verma at the Center for Medicare and Medicaid Services U.S. Department of Health and Human Services, regarding our concern for beneficiaries’ barriers to accessing off-label treatments in Medicare Part D.

August 2019

  • Submitted comment letter regarding the administration’s proposed rule that would dramatically change the regulations that implement Section 1557, the anti-discrimination provision of the Affordable Care Act. The letter focuses on the impact of the proposed changes that impact benefits design and access to care and treatment for people with serious, chronic health care conditions.

September 2019

  • The IPPF joined 17 organizations as part of the American Academy of Dermatology (AAD) Drug Pricing Task Force signed on to the biosimilars principles document that supports common
    principles around increasing uptake of biosimilar biological products.

October 2019

  • Sign-on letter to the leadership of the Senate Finance Committee and the leadership of the House Energy and Commerce Committee and the House Ways and Means expressing our continued support for a long-term re-authorization of PCORI, and as they negotiate a health extenders package.
  • Submitted comments to the Institute for Clinical and Economic Review’s (ICER’s) proposed changes to the ICER Value Framework for 2020.

November 2019

  • Signed a letter of support for the swift confirmation of Dr. Hahn as FDA Commissioner.

December 2019

  • Signed on to a letter to Senators Jones, Collins, Menendez, and McSally thanking them for introducing the Senate version of the “Ending the Diagnostic Odyssey Act.”
  • Signed on to letter to to Representatives Diana DeGette and Fred Upton providing input as Congress considers legislation to build upon the success of the 21st Century Cures Act by facilitating a modernized system of developing new cures combined with a health care system that delivers coverage and access.
  • Signed on to letter to Speaker Pelosi, Majority Leader McConnell, Minority Leader McCarthy, and Minority Leader Schumer urging them to complete final negotiations on the fiscal year 2020 Defense Appropriations Act and move the bill expeditiously through the House and Senate toward enactment. Legislation will prevent delay to Defense Health Research Programs, including the Congressionally Directed Medical Research Programs, at the Department of Defense (DoD).

February 2018

  • The IPPF sent a letter to Medicaid Directors across the country emphasizing the importance of preserving patient access to orphan therapies in Medicaid.

March 2018

  • The IPPF joined the Friends of NIDCR requesting research funding of $38.4 billion for NIH, which includes funds provided to the agency through the 21st Century Cures Act, and $477 million for NIDCR, a 12 percent increase over FY2017 levels.
  • The IPPF sent a letter to Congress expressing our concern with, and opposition to, the latest version of the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act.

April 2018

  • The IPPF signed on to support the RARE Act (Rare disease Advancement, Research, and Education Act) of 2018 (H.R.5115), introduced by Congressmen Carson and Costello.
  • The IPPF signed on to a letter to congress to express our concerns about the impact the proposed rule regarding short-term limited duration plans (STLDs) (CMS-9924-P) will have both on the health insurance marketplaces and the individuals we represent. http://www.heart.org/idc/groups/heart-public/@wcm/@adv/documents/downloadable/ucm_500479.pdf
  • Sent letter to the U.S. House of Representatives asking them to amend the Employee Retirement Income Security Act of 1974 to require a group health plan (or health insurance coverage offered in connection with such a plan) to provide an exceptions process for any medication step therapy protocol, and for other purposes (H.R. 2077).

July 2018

  • Signed on to a letter outlines proposals the Administration could take to lower patient cost-sharing since patients with serious and chronic health conditions often shoulder the heaviest cost burden and are faced with high out-of-pocket costs, such as increased premiums, higher deductibles, rising copays and co-insurance. All of which can have an impact on medication abandonment and adherence.

August 2018

  • The IPPF signed a letter that we will be sent to appropriators in advance of their conference on fiscal year 2019 appropriations legislation. The letter requests that appropriators fund of the National Institutes of Health (NIH) and the National Institute of Dental and Craniofacial Research (NIDCR) be at a level equal to or higher than the Senate Appropriations Committee marks of $39.1 billion and $462.024 million, respectively.

November 2018

  • The IPPF signed onto a letter on behalf of the Part B Access for Seniors and Physicians (ASP) Coalition, which represents a broad cross-section of U.S. health care providers and patient advocacy organizations committed to advancing life-saving innovation in the U.S.

February 2017

  • Health Coverage Reform Sign-on Letter to the House Energy and Commerce Committee expressing serious concern about the Preexisting Conditions Protection and Continuous Coverage Incentive Act of 2017.
  • Sign-on letter with 200 patient organizations to newly confirmed U.S. Department of Health and Human Services (HHS) Secretary Tom Price urging him to maintain and enforce the ACA’s patient protections as he reviews the law and its implementing regulations.
  • Sign-on letter to the Trump Administration about the challenges facing rare disease patients in America and the vital role that federal agencies play in helping to accelerate the research, development, review, and approval of treatments. These agencies must have the ability to hire and retain personnel in order to accomplish their respective missions and to achieve the broader goal of treating and curing diseases.

March 2017

  • Sign-on letter in opposition to the new version of this bill – HR 1313 to the House Education and Workforce Committee . This legislation would fundamentally undermine the privacy provisions in the Genetic Information Nondiscrimination Act (or ‘GINA’), and the Americans with Disabilities Act, allowing workplace wellness programs to require individuals to provide their health and genetic information and that of their families, and to impose severe penalties on those who decline to do so.
  • Sign-on letter to Senate Majority Leader and Speaker of the House expressing grave concern about proposals put forth in the American Health Care Act (AHCA) to alter the fundamental structure and purpose of Medicaid, a vital source of health care for patients with ongoing chronic health needs.

April 2017

  • Sign-on letter with The National Health Council (NHC) and the National Organization for Rare Disorders (NORD) are circulating the attached sign-on letter for patient organizations to join us in supporting of timely reauthorization of the Food and Drug Administration’s (FDA) user fee agreements. People with chronic and rare diseases and disabilities rely on FDA to access innovative, safe, and effective treatments.
  • Sign- on letter with the Friends of NIDCR to congressional leadership urging them oppose the Administration’s budget proposals, provide the Senate Appropriations Committee approved allocation of $430.5 million for NIDCR in the final FY17 appropriation bill and our recommended level of $452 million for NIDCR in the FY18 bill.
  • Sign-on letter with The Patient Access to Community Treatment (PACT) Coalition is concerned that the Medicare Payment Advisory Commission’s (MedPAC) proposed recommendations to reduce Medicare payments for Part B medicines could limit patient access to community-based care.

May 2017

  • Sign-on form urging Congress to engage in trade negotiations supporting policies that foster medical innovation. Patients need new cures and better treatments.

June 2017

  • Sent letter with NORD requesting the establishment of the FDA Office of Patient Affairs to help engage patients more effectively.
  • Joined the Cystic Fibrosis Foundation and other rare disease groups in sending a letter to Senate leadership on the importance of Medicaid to our communities and in opposition to cuts to Medicaid.

July 2017

  • We joined 133 organizations in supporting @IAmEssentialCoalition’s response to @HHS’ Request for Information (ROI) on ways to reduce regulatory burdens and improve health care choices to empower patients. http://bit.ly/2uRYbde

August 2017

  • The IPPF joined the National Organization for Rare Disorders (NORD) to express our combined support of the Orphan Drug Tax Credit (ODTC) by sending a letter to Congress.

November 2017

  • Signed FDA letter sponsored by the Sjögren’s Syndrome Foundation and the American Autoimmune Related Diseases Association regarding eye health providing expanded access to generic ophthalmic emulsion drug products.
  • The IPPF joined 200 patient organizations in sending this updated letter to Congress in emphatic support of the Orphan Drug Tax Credit.
  • Joined Orphan Drug Credit Coalition along with 34 organizations to advocate preserving the Orphan Drug Tax Credit.
  • Joined Friends of NIDCR sign-on letter to appropriators with our 2018 funding requests for both NIH and NIDCR.

January 2016

  • Sign on to letters Urge Obama Administration to Enforce ACA Nondiscrimination Provisions; and support of the 21st Century Cures Act (HR 6)

March 2016

  • Sign on to letter for Newborn Screening

April 2016

  • Sign on to letter to Senate HELP Committee Chairman Lamar Alexander and Ranking Member Patty Murray in support of their efforts to advance Innovations legislation bolstered by supplemental funding for NIH.

October 2016

  • Sign on to Rare Pediatric PRV Program as part of 21st Century Cures Act

January 2015

  • Sign on to letter To Bring Treatment to Patients with Rare Diseases

February 2015

  • Sign on to letter for OPEN ACT

April 2015

  • Sign-on letter supporting H.R. 1078, the SOS Act.

March 2015

  • Sign-on letter opposing undoing GINA
  • Sign On Letter to Ensure Medicaid patients with rare diseases access to prescribed therapy.

April 2015

  • Sign-on letter supporting H.R. 1078, the SOS Act.

May 2015

  • Sign On to Show Support for Continuing Incentives for Manufacturers Seeking Pediatric Rare Disease Indications.

June 2015

  • Joined National Health Council 21st Century Cures Sign-on Letter

July 2015

  • Signed on to the letter in support of the $10 billion NIH Innovation Fund, which is included in the 2nd draft of the 21st Century Cures legislation.
  • Joined United for Medical Research and the National Health Council in opposing the Brat amendment that cuts critical NIH funding in the 21st Century Cures Act through Politico ad campaign.

October 2015

  • IPPF added to Sign-on letter with PPMD to Chairman Alexander and Ranking Member Murray regarding Enhanced Patient Engagement.
  • IPPF added to Sign-on letter with NORD supporting the Advancing Targeted Therapies for Rare Diseases Act (S.2030).

November 2015

  • IPPF added to sign-on Letter in support of Dr. Robert Califf for the position of commissioner of the Food and Drug Administration