- The Venn Team sent the letter (attached) to House, Senate, and Appropriations Staff to preserve the PI language last week.
- On Monday, ahead of the House Appropriations Ag/FDA Subcommittee Markup, we found out that our preferred PI language (below) was included in the subcommittee’s proposal.
- The bill will be reviewed by the full House Appropriations Committee. A date has yet to be announced.
“Provided, none of the funds made available by this Act may be used to promulgate, propose, or implement any rule, or take any other action with respect to, allowing or requiring information intended for a prescribing health care professional, in the case of a drug or biological product subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)), to be distributed to such professional electronically (in lieu of paper form) unless and until a federal law is enacted to allow or require such distribution.”
- The Venn Team will circulate a package of information to PPLA membership with:
- A draft note to staff;
- PPLA letter;
- The Myth vs. Fact Sheet (pending board approval); and a
- Staff contact list.
- E-Street is about two-thirds of the way though the Phase 1 of testing. To date, the petition has collected 2,408 petition signatures.
- This campaign is expected to be completed by next Wednesday (7/15).
- Please fill out the Member Survey (attached), if you have not already. We appreciate those who have already done so.
Alliance to Modernize Prescribing Information
- AMPI’s goals are aimed at PI and are targeted at the removal of the Appropriations language.
- Steve Fier has already reached out to the Maine delegation. They are all supportive and will help us in this fight.
- Amid the AMPI news, concerns were raised about moving forward with the grassroots PMI campaign.
- The work with E-Street, such as the man on the street video, will help PPLA connect with more people and build support.
- The Venn team recommends going forward with PMI and keeping any PI conversation separate when discussing the matters with the Hill.
- There was consensus that the coalition and others must rally like they did for Section 8.
- Under the current circumstances, it is hard to determine the timing and the length of any appropriations vehicle that could move through Congress.
- Both Senator Susan Collins (R-ME) and Jared Golden (D-ME), our champions, are up for re-election. Both know how important the appropriations language is to their constituents.
- A letter with 15 members has already gone to House Appropriations committees.
- This current situation presents an opportunity to reach out to AFPA and other organizations to add strength and diversity to the coalition.
- Circulate strategy document, including but not limited to.
- Create a one pager highlighting the false claims on the AMPI one pager.
- Proactively reach out to third-party partners and pharmacy groups.
- Send Member Alert email to launch the new website with important news on the portal.
- The Venn Team has been in contact with a number of third-party organizations:
- The Celiac Disease Foundation has offered their support for HR 5198 and has reached out to their congressional champions asking that they support our bill. Venn is soliciting their interest in writing a letter of support that could include other stakeholders in the Celiac Disease community.
- The Anxiety and Depression Association of America (ADAA) sent a letter to Reps. Golden (D-ME) and Carter (R-GA) in support of the legislation.
- Calls have been scheduled with Mental Health America, Consumers Advancing Patient Safety, Food and Allergy Research & Education.
- Third-party support helps engage diverse constituencies and helps build grassroots momentum.
- The Venn team has continued have conversations with the following offices:
1. Jim Cooper (D-TN)
2. Denny Heck (D-WA)
3. Colin Allred (D-TX)
4. Mary Gay Scanlon (D-PA)
5. Joe Neguse (D-CO)
6. David Trone (D-MD)
7. Lori Trahan (D-MA)
8. Lauren Underwood (D-IL)
New PPLA Website
- Updates to the news page, the member portal, and the downloadable content will be made by next week’s webinar.
- As a reminder, the password to the website is PPLA2020!!
- If information about the domain is found, please let Bridget know.
- Please fill out the Member Survey (attached).
- Join us on Tuesday, May 12th, at 1:30 PMto discuss what’s happening in D.C., the Patients’ Right to Know Their Medication Act of 2019, and the new PPLA website and communications plan.
- Please see the Zoom information below:
- Videos will be made into 20-30 second clips used for social media purposes.
- Longer videos will live on the website.
- Concerns with Video B include:
- The inaccurate and negative portrayal of PI versus what is distributed at the pharmacy.
- The risk it poses to eliminate other types of printed literature including PI, a product PPLA has spent significant time and resources to protect.
E-Street Proposal (attached)
- The purpose of creating a 501c4 entity is to shield the spotlight from PPLA and to echo PPLA’s messages.
- A new organization could make advocacy more complicated and difficult since PPLA has established itself as the leader on the issue.
- From Venn’s perspective, it’s more important to have organizational support of the legislation than a membership to a new entity.
- The PPLA board approved Venn’s role to coordinate directly with E Street on their work.
- Additionally, the board agreed to go forward with the website and social media pages and to hold off on digital advertisements.
- Next board call is on Tuesday, May 5 at 1:30 PM EDT. Information to participate will be sent out shortly.
- Please fill out the member surveythat is attached to help us better understand your company’s footprint around the country.
- Venn continues to meet with offices to garner support for the legislation.
- Venn and Rich Scholz are exploring opportunities to amend current legislative proposals to include PMI language with the following offices:
- Rep. Bobby Rush (D-IL) introduced the H.R.4404 – Depression Side Effect Labeling Awareness Act of 2019 to require that the label of drugs with an increased risk of suicide or depression present such increased risk prominently, and for other purposes.
- Rep. Tim Ryan (D-OH) introduced the H.R.2074 – Gluten in Medicine Disclosure Act of 2019 that would amend the Food, Drug, and Cosmetic Act to require that “the label of a drug that is intended for human use and contains an ingredient that is derived directly or indirectly from a gluten-containing grain to identify each such ingredient.” This bill has 50 cosponsors in the House and Senate companion language in the Senate.
Mini Fly-In Wrap Up
- Please continue to send thank yous (below) to the offices you visited during the mini fly-in in February. Attached is the bill’s one-pager for you to send to staff, (along with our request that the Member join as a bill co-sponsor), and your follow-up assignments (attached). Please BCC the Venn team member that accompanied you at the meeting.
Spring fly-in – April 28 and 29
- Confirmed attendees:
- Dave Joesten
- Sue Steller
- Robin Henfling
- Russ Haraf
- Terry Griffis
- Tim Jones
- Dave Anderson
- Jimmy DeLise
- Greg Groeschel
- Please let me know if you would like to be added to this list.
- I will send a follow up email to the coalition next week, please feel free to reach out to individuals you think would be interested in attending.
- Venn proposed a quarterly call with the coalition writ large and is working through logistics. We will send an update to you next week.
- For your review, attached is a spreadsheet for PPLA members to fill out relevant information including HQ, facility locations, facility types, and employee counts, to assist our Hill strategy. Please let us know if you have any concerns.
Marketing Project Updates
- Russ shared that digital assets should be available for distribution prior to the spring fly-in.
- Dinner on Tuesday, February 11th will be held at Bistro Bis at 7 PM.
- Fly-in attendees will receive their folders and finalized schedules at dinner.
- 19 meetings have been confirmed as of 2/4.
- Venn will send fly-in information to the general membership.
- PPLA Board members will encourage other member organizations and colleagues to attend.
- Venn is continuing to meet with offices on the Hill this month and next.
- Reps. Pingree (D-ME) and Ruppersberger (D-MD) have agreed to cosponsor.
- Please continue to follow up with Members of Congress and their staff. We strongly encourage you to ask your coworkers, friends, and family to reach out.
- A letter template is below.
- Please be sure to include both the legislation PPLA-branded legislation one-pager (attachment 1) and bill text (attachment 2).
- To assist in locating the appropriate healthcare staff, the third attachment lists House offices, (alpha by state).
Marketing Project Updates
- Video project will be filmed on February 19 in Florida.
- Digital assets are on track for deployment by April 1st.
- Russ is following up with a DC PR firm to discuss other channels and tools to promote the campaign.
- PPLA Board and Venn have reached out to almost 120 congressional offices since the bill’s introduction. These offices include members of Energy and Commerce, signatories of the sign-on letter, and those we met with during the fall fly-in.
- We will continue to meet with offices when Congress returns in January.
Grassroots Follow Up
- Please continue to follow up with Members of Congress and their staff. We strongly encourage you to ask your coworkers, friends, and family to reach out this week or beginning the week of January 7th. Your voice is critical in moving this bill forward.
Proposed 2020 Fly-ins
- We discussed a mini fly-in for board members on February 4th and 5th.
- As for the spring fly-in, the original proposed dates were April 28th and 29th. However, we were made aware of a conflict with a trade show that PPLA members may be attending. Below the options. Please let me know your preference by January 3rd.
- Option #1: April 21-22
- Option #2: April 28-29
- Options #3: May 13-14
Marketing Team Updates
- The board approved continuing work with marketing professionals to create assets for use by April 1st. These assets include the scenes, the man on the street segment, and a 3D animation. The projected budget is $35,000.
- Last Friday, Legislative (leg) Counsel made changes to the bill that included NCL’s language.
- Venn and Rich added language to explicitly note that manufacturers are responsible to print and distribute PMI. The updated legislation was sent back to leg counsel on Monday.
- After legislation is amended, Congressman Carter’s office will have to OK the revised legislation.
- Once introduced, there will be various advocacy opportunities for PPLA members including:
- Thank you letters to sponsors of the bill;
- Follow-up emails to offices we met during the fly-ins;
- Co-sponsorship letters/requests for friends, family and colleagues;
- Mini Fly-in (early January/February); and
- Board Fly-in (Late April).
- Venn will create materials for use.
- Venn is talking with Senate offices about a bill.
- Russ has been working with marketing professionals at CCL and NOSCO on a digital ad campaign, a 3D video, and a “Man on the Street” segment.
- Venn recommends microtargeting the digital ads to coincide with congressional districts. This collateral can be helpful when asking for co-sponsors.
- Venn will provide a shortlist of congressional targets and will identify metrics to measure success.
- Congressman Golden expressed the need for consumer support before introducing the legislation.
- Without our knowledge, his office shared the draft legislation with AARP.
- As a compromise to AARP’s concerns, the idea of a 5-year sunset clause was suggested. At that time, the Secretary would review the data (medication safety, adherence, technology, etc.) and anything else that might be relevant to make necessary or appropriate changes. Then the Secretary would have to produce a similar report every year.
- The Board raised various concerns on the proposal.
- Venn plans to go back to Golden’s office with the support of consumer groups with the original legislation.
Third Party Outreach
- Venn successfully secured the Association for Mature American Citizens’ (AMAC) support of the original legislation. They will write a letter in support of the bill.
- Venn spoke with the National Consumers League and they are interested in supporting the legislation. They had a couple of helpful ideas and Venn and NCL are communicating now on a path forward.
- Pace is reaching back out the National Indian Health Board (NIHB) and California Association of Veterans Service Agencies (CAVSA).
- Dinner will be at Lavagna from 6 – 9 PM. The dinner options and layout will be similar to the May fly-in.
- Pace is continuing to reach out to members to encourage their attendance next week.
- If interested in donating, please email me with the amount you’d like to pledge.
- Congress is currently in recess. They will return next week.
- Our bill is currently being reviewed by legislative counsel.
- The hope is that Reps. Carter/Golden will introduce the bill when Congress returns next week, at which time it will be given a bill number.
- Once the bill is introduced, the Venn team will draft an update that can be shared with the entire PPLA membership.
Mini Fly-in Update
- The goal of the mini fly-in is to meet with offices in the hopes of increasing the list of cosponsors for the legislation.
- Bryan is in the process of scheduling meetings. He’ll be sharing a meetings list shortly.
- For dinner, Bryan is planning to accommodate Sue, Rich S., and Alex.
- Bryan is working to set up meetings for Russ on September 24.
October Fly-In Update
- Bryan solicited feedback from the Board on the draft agenda he shared last week last week.
- Please review and let Bryan know if you have any thoughts.
- As has been the case in previous fly-ins, Venn will host the meetings and dinner will be held in the evening of day #1.
- The big difference between this draft agenda and previous fly-ins is that Hill meetings will take place over the course of both days.
FDA Comment Letters
- Rich S. drafted comment letters on behalf of PPLA for the following pieces of draft guidance from FDA –
- The board received the comment letters yesterday and had no objections.
- The comments were shared with FDA yesterday and a note will be shared with the PPLA membership once the comments are posted.
NDAA Policy Rider
- The Twin Rivers team has asked the Board to send a letter to Senate Conferees concerning the House NDAA bill.
- The PPLA board has agreed to send the letter and Venn will take the lead in drafting. Venn will have a draft letter to share with the board shortly. The letter will be sent to conferees on Friday, September 6.
Video Proposal Deck
- Russ has received initial thoughts from Venn, Pace, and Rich.
- Alex presented the draft deck to the CCL Marketing team and will be sharing their thoughts over email shortly.
- The most significant takeaway was that the project didn’t have a long enough runway.
- The Board agreed and it was decided that the campaign would set a loose target date of Spring 2020.
- Two other ideas that were discussed include a “man on the street” interview and the incorporation of a data security/privacy angle.
- Venn made the suggestion that if hiring actors proved too cost-prohibitive, the Board should consider doing an animatic video that explains the issue.
- Venn will work with the Board to get quotes. Quotes will be presented to the general membership during the fall fly-in.
- It was also suggested that the Board create a special working group that will focus on the video.
- Attached for your review:
- One-pager explainer on the legislation
- Letter to your representative
- Friends and Family Letter
- Please send any comments to me by COB on Monday, August 12.
- Venn to start initial outreach to offices to cosponsor the bill next week.
September Mini Fly-in
- The mini fly-in will take place on Wednesday, September 11.
- Please let Bryan know if you are able to attend the fly-in ASAP.
- Pace will send the first round of meeting requests next week.
Timeline of Legislation
- The legislation will formally be introduced the week of September 9.
- Through the fall:
- Meet with committee staff
- Meet with congressional leaders
- Potential vehicles:
- Medicare Extenders
- Heath package from Senate Finance and HELP committees
Institute of Packaging Professionals (IOPP)
- Rumors are circulating that IOPP may be trying to take aim to eliminate printed PI.
- Please check to see if any clients are a part of the IOPP to be our advocates internally.
Social Media Campaign
- Russ created a storyboard for a potential marketing video. He will circulate the PowerPoint to Venn, Pace, and Rich to rank scenes.
FDA Draft Guidance
- This week, in a joint statement, Acting FDA Commissioner Ned Sharples and the Director of the Center for Drug Evaluation and Research Janet Woodcock outlined FDA’s plans to “make health care professional and patient labeling information for prescription medications consistent and clear.” Their full statement can be found here. They also announced two pieces of draft guidance pertaining to prescription drug labeling. Comments for both are due September 3rd.
- The draft guidance documents do not address PPLA’s position on labeling entirely. However, it gives PPLA and member companies an opportunity to maintain momentum, voice support for the FDA’s perspectives, and formalize the importance of patient safety for all prescription drugs through comment letters.
- Rich will take the lead on drafting comments for both guidance documents and Venn will support. Draft comments can be expected for board review in August.
FDA Proposed Meeting
- The meeting request is in process at the FDA.
- Venn met with Rep. Schneider (D-IL) on the Ways and Means Committee and Rep. O’Halleran (D-AZ) on the Energy and Commerce Committee. Offices have until July 8th to decide if they would like to proceed as the lead democrat. If not, we will be in touch with Rep. Golden (D-ME).
July Mini Fly-ins
- Pace will solidify dates and meetings for those available to come in mid-July.
Post Fly-In Notes and Next Steps
- PPLA members held 50 meetings with Members and Congressional staff last month. Pace and Venn have followed up with offices and staff we met with, providing information on relevant studies and supporting information as requested. Several offices have indicated their willingness to consider co-sponsoring PMI legislation after introduction.
Patient Medication Information (PMI) Legislation Update
- Rep. Buddy Carter (R-GA) has agreed to be the Republican sponsor of the bill.
- The Venn team will be connecting with senior staff from the office of Rep. Peter Welch (D-VT) later this week in the hopes of securing his commitment to serve as the Democratic sponsor of the bill.
E-Labeling FY 2020 Policy Rider
- Earlier this week, the full House Appropriations Committee passed the Agriculture-Rural Development-FDA Subcommittee’s bill. Included in the Subcommittee bill was the e-labeling policy rider (text identical versions approved in previous sessions of Congress). The full bill now heads to the House floor for consideration of any amendments and votes.
Medication Dispensing Requirements for Military Facilities – House Armed Services Committee
- Earlier this week, the House Armed Services Subcommittee on Military Personnel included and approved a policy rider requiring drugs made available through military facilities include labels that are printed and physically located on or within the package from which the drug is to be dispensed and provide adequate directions for use. The full House Armed Services Committee will consider final passage of the Subcommittee’s bill on June 12th.
FDA Semi-Regulatory Agenda (Spring 2019)
- Last week, the FDA issued its Spring 2019 regulatory agenda. The PMI proposed rulemaking is scheduled for its initial publication in November 2019. The long-stalled PI proposed rulemaking remains on the “long-term” agenda, but does not have any dates assigned for its implementation.
- On the call, the Board discussed the idea of setting up a meeting with FDA to discus PPLA-related issues. The Board seemed generally supportive of the idea so long as the meeting was scheduled after the bill is introduced. Once the bill is introduced, Venn will run point on securing a meeting at FDA.
- Pace has continued to be in contact with organizations that have a demonstrated interest in paper-based issues of concern to PPLA. The National Indian Health Board (NIHB) is supportive of keeping paper-based PI for their constituency. NIHB is also interested in supporting (letters, emails, as directed) the forthcoming PMI bill, as they view a standardized PMI as beneficial. Pace will continue to facilitate this effort, and share with leadership from the National Congress of American Indians (NCAI) for their support as well.
- The California Association of Veterans Service Agencies (CAVSA)reviewed PPLA background and one-pagers at their Board meeting in May. They are supportive of keeping printed and paper-based information for prescription drugs and medications, as their veteran constituency do not need additional healthcare challenges. CAVSA may be supportive or sign on to letters for the forthcoming PMI legislation after they have had a chance to review.
- Russ mentioned the development of a PPLA produced video, to promote the industry’s core initiatives and legislative efforts, which was discussed during the Board’s Executive Session last month. There was general agreement that this effort is worth fleshing out. First steps would be to identify companies that could provide the video, overall costs, and video script. Venn will review prospective companies that they currently work with for associated costs and timeline.
- Individual reminders have been sent to each of the members from Pace.
- Jimmy DeLise from Mini Graphics is a new addition – that puts us at 23 confirmed fly-in attendees.
- Pace is still waiting to hear back on 4-5 members about their availability.
- Pace has shared tentative schedule with the board.
- The reception and dinner will be at DC Chophouse. Seating will be by team.
- Based on feedback, Pace/Venn will look to make the lobbying groups smaller in size (3-4 PPLA members per meeting).
- Meetings for the May fly-in will be focused on the House. Tiers include –
- Relevant committees
- Constituent footprints
- Health care focused members
- Venn/Pace will participate during the fly-in board meeting except for a thirty minute executive session –
- Pace will present on 3rd party coalition building.
- Venn will present on coordination of consultants and congressional strategy.
- An agenda will be shared with board in advance of the fly-in.
- Rooms are no longer available through the room block – members who haven’t booked already are on their own.
- Thanks to Rich for crafting the PMI bill and for updating citations.
- Venn is meeting with Reps. Peter Welch (D-VT) and Buddy Carter (R-GA) to gauge their interest in introducing the bill.
- The bill would apply the PI template for PMI
- Senator Shelley Moore Capito (R-WV) has agreed to lead.
- Her office is open to changes depending on the timing of the regs.
- Senate meetings during the fly-in will be focused on finding a Democratic lead.
- All consultants, led by Steve Fier and Twin Rivers, were able to secure 20 signatures on a letter led by Reps. Jared Golden (D-ME) and Peter King (R-NY) on an e-label policy rider letter.
- The letter requested that leadership from the House Appropriations Committee’s Subcommittee on FDA include language identical to the Collins language.
- Once House language is proposed, Venn suggesting additional opportunities for members to come into town in June/July to solicit support for the bill.
- The board was receptive to this idea.
- In a larger conversation around political giving, Venn floated the idea of possibly hosting a fundraiser during the May fly-in for Rep. Peter Welch.
- The board requested that Venn/Pace send and email to the membership to gauge interest.
- Venn also plans to give a “PAC 101” during May’s fly-in to gauge interest.
- Rich mentioned that it’s important for consultants to continue to monitor congressional activity around drug pricing for potential impact on PPLA.
- Conversations around third-party development are ongoing. Pace is taking a lead.
- Venn had a conversation with AARP’s health care team and they don’t have the interest nor bandwidth to engage on this issue primarily because they have not heard from enough of their membership on the issue to justify them getting involved.
- Also discussed – coordinated media push around legislation. Consensus that education around the PPLA issue set is critical.
- House Letter
- 21 signatures
- Congressman Peter Welch (D-VT) or Congressman Buddy Carter (R-GA-1) plan to send the letter to the FDA COB today or tomorrow
- Once we have a copy of the signed letter, Venn will send it to the board.
- Senate Letter
- Senator Shelley Moore Capito (R-WV) has agreed to lead the letter
- Venn is trying to get a Democrat lead
- Depending on the timing, our ask in the Senate letter may change.
- Venn will be circling back with Congressman Peter Welch (D-VT) and Congressman Buddy Carter (R-GA-1) to ask if they are willing to lead the legislation.
FY 20 FDA Appropriations
- Senator Susan Collins (R-ME) has agreed to champion the policy rider once again for FY 20.
- Congressman Jared Golden (D-ME-2) will submit the policy rider on the House side and Congresswoman Chellie Pingree (D-ME-1) has agreed to support it.
- 15-16 members are confirmed. Bryan (Pace) will continue to follow up with folks.
- The board meeting on Tuesday, May 7 will take place at Venn.
- Still waiting for confirmation of a private room at Art and Soul for Tuesday’s dinner.
- Hotel arrangements will be the same as last fly-in. Bryan will send out links to folks.
Discussion on a FDA Meeting
- There was discussion brought up by Rich Scholz to meet with the FDA about the PMI rule. This meeting would be an information gathering exercise in concert to the legislative approach. It would serve as a guide to Congressional and legislative approaches.
- Terry Griffis raised concerns about needing Commissioner Gottlieb’s response to the questions for the record (QFRs) Venn submitted to Congressional members for the Appropriations hearing held on February 27.
- Alex Joesten suggested that it may be worth while to work with the FDA rather than against them.
- Michelle Seger (Venn) suggested we find a lower stakes platform ( an FDA public conference or forum) to ask a question to an official.
- Bryan will be sending a list of potential partners that we could work with.
- Bryan will be sending a list of potential partners to the board by Friday.
- Venn will send official House letter to the board.
- Venn will look at the FDA calendar for relevant events.