Grassley, Wyden Press for Answers on Financial Relationships Between Opioid Manufacturers and Tax-Exempt Organizations

WASHINGTON – Senate Finance Committee Chairman Chuck Grassley (R-Iowa) and Ranking Member Ron Wyden (D-Ore.) sent letters to 10 tax-exempt organizations, including pain advocacy groups, professional associations and medical associations, requesting information about their financial relationship with opioid manufacturers and other medical entities.

“We write to request information regarding your organization and its financial relationship with opioid manufacturers and other entities that manufacture products to treat pain. As Chairman and Ranking Member of the Senate Finance Committee, we have a responsibility to ensure transparency and accountability in matters that directly affect Federal healthcare programs and tax-exempt organizations. This responsibility includes examining the extent to which pharmaceutical manufacturers fund tax-exempt organizations and how these payments may influence pain treatment practices and policy,” the senators wrote.

“We acknowledge that the answer to the opioid epidemic continues to be anything but simple. However, we believe that it is important to shed light on these financial relationships to ensure transparency and accountability in matters that affect Federal healthcare programs and the patients that participate in them.”

The letters were sent to the following:

• American Chronic Pain Association
• American Pain Society
• American Society for Pain Management Nursing
• American Society of Pain Educators
• Center for Practical Bioethics
• Federation of State Medical Boards
• The Joint Commission
• American Academy of Physical Medicine and Rehabilitation
• Alliance for Patient Access
• International Association for the Study of Pain

Text of the letter is available here and below.

Dear [Recipent],

We write to request information regarding your organization and its financial relationship with opioid manufacturers and other entities that manufacture products to treat pain. As Chairman and Ranking Member of the Senate Finance Committee, we have a responsibility to ensure transparency and accountability in matters that directly affect Federal healthcare programs and tax-exempt organizations.  This responsibility includes examining the extent to which pharmaceutical manufacturers fund tax-exempt organizations and how these payments may influence pain treatment practices and policy.

This Committee has a long history of investigating pharmaceutical manufacturers and their relationships with tax-exempt entities that influence pain treatment practices and policy.  In 2012, Chairman Grassley, along with then-Chairman Max Baucus, initiated a bipartisan investigation into the connection between opioid manufacturers and non-profit medical organizations and physicians. The purpose of this investigation was to understand the nature of these relationships and to determine the extent to which they were responsible for promoting misleading information about opioid safety and effectiveness. During the investigation, the Committee stressed the importance of distributing accurate information about these drugs in order to prevent improper use of opioids for chronic pain, but was unable to complete the investigation before the end of the 112^th Congress.

In recent years, Ranking Member Wyden has identified a dozen individuals and tax-exempt organizations with significant financial ties to opioid manufacturers who have been appointed to various federal panels charged with making decisions and recommendations relating to opioid prescribing practices. In December 2018, the Ranking Member initiated an investigation examining conflicts within medical advisory boards and asked the Department of Health and Human Services (HHS) for information relating to apparent conflicts within its Pain Management Best Practices Inter-Agency Task Force (Task Force), as well as Task Force members affiliated with the U.S. Pain Foundation and American Academy of Pain Medicine. Based on information from the Centers for Medicare & Medicaid Services’ Open Payments database, some members on the Task Force have received tens of thousands of dollars from opioid manufacturers. It is imperative that Congress ensure that these organizations and their members are adequately disclosing these conflicts to the Federal government to ensure that their guidance remains objective and transparent to the medical community and to patients.

The stakes are high. The Centers for Disease Control and Prevention has estimated that 130 people die each and every day from deaths involving prescription opioids and that around 68 percent of the more than 70,200 drug overdose deaths in 2017 involved an opioid. These figures demonstrate that the U.S. continues to suffer from an opioid epidemic and that taking prescription opioids for an extended period of time or in higher doses increase a patient’s risk of opioid addiction, overdose, and death. At the same time, the relationship between opioid manufacturers and non-profit medical organizations remains robust, which calls into question their ability to make impartial recommendations to the medical community and to patients on opioid prescribing practices.

We acknowledge that the answer to the opioid epidemic continues to be anything but simple.  However, we believe that it is important to shed light on these financial relationships to ensure transparency and accountability in matters that affect Federal healthcare programs and the patients that participate in them. Therefore, we ask that you please provide the following information to the Committee no later than July 29, 2019:

1. Please provide complete Form 990s that your organization has filed with the Internal Revenue Service for each year from 2012 to the present. In your submission, please also provide complete Schedule Bs.

2. Please provide a detailed accounting of all payments/transfers (including but not limited to contributions, grants, advertising, program sponsorship, and other revenue or remuneration) received from any manufacturer of drugs, devices, biologicals or medical supplies and individuals that produce, market, or promote products on these entities’ behalf. Please provide this information in hard copy, PDF, and in a Microsoft Excel workbook. For each payment identified, provide:

1. Date of payment.

2. Source or entity making the payment.

3. Payment description (general support, project specific etc.).

4. Amount of payment.

5. Year-end or year-to-date payment total and cumulative total payments for each organization or individual.

6. For each year a payment was received, the percentage of funding from organizations identified above relative to total revenue.

3. In addition to financial support, identify and describe any collaborative activity between your organization and the entities identified in Question 2 from 2012 to the present and the timeframe in which such activity took place.

4. Does your organization maintain a conflict of interest policy? If so, please provide us a copy of the current policy and tell us how long this policy has been in effect. In addition, please describe any additional mechanisms your organization uses to police conflicts of interest and to promote transparency of funding sources.

5. Regarding involvement with the Federal government:

1. Has your organization received any funding from the Federal government since 2012? If yes, please list the year, amount, and purpose of this funding in hard copy, PDF, and in a Microsoft Excel workbook.

2. Please provide copies of all comments or other written materials that your organization has made to Federal task forces, committees, advisory groups or other similar entities from 2012 to present.

3. In the event any activity identified in Questions 5a and 5b pertains to information distributed to physicians and patients concerning prescription pain medications, please identify any materials developed, in whole or in part, by organizations identified in request Question 2, please provide copies of these materials.

4. Please provide a list of all instances from 2012 to present in which a board member, executive, staff or affiliated volunteer has served on any Federal task force, committee, advisory group or other entity.

6. Please identify any person employed by your organization who communicated with an entity identified in Question 2 regarding the content of materials distributed to patients and physicians pertaining to opioid use and/or prescribing practices from 2012 to the present. Please include their name, position, dates of employment, and job description. Please provide this information in hard copy, PDF, and in a Microsoft Excel Workbook.