Congressional Contact/Request for Action
 Included:
 Three similar draft letters from PPLA members to Representatives and Senators
 Draft letter for employees, friends, family, etc.
 Supporting bullet points (for use as talking points to use in your correspondence/responses)
 Key points of GAO report attached as well (independent, credible source that said electronic as a complete
substitute for paper “could adversely impact public health”—good as a follow up)
 Instructions for PPLA letters:
 Review draft letter
 Insert your company’s relevant information for the specific location
 Items bolded throughout the letter
 Print it on the local letterhead and have it signed by the local facility manager/director
 A local constituent
 And/or, if time and logistics allow, consider having employees sign an accompanying sheet to support the
letter
 Scan and email a copy to the Member’s staff
 We will provide you with the contact information
 Fax a copy to the Member’s office
 Copy to the attention of those to whom you emailed it
 We will provide you with the contact information or you can find it on the Member’s website
 Send a hard copy to Amanda for hand delivery to the Members’ offices:
 Evergreen Associates
c/o Amanda Powers
415 2nd Street NE, Suite 100
Washington, DC 20002
 Instructions for employees, friends, family, etc.
 Provide the draft to employees, friends, family, etc.
 They should make the letter more personal if they would like
 Ask them to consider sending it to their Representatives and Senators
 Congressional office contact information can be found at www.house.gov and www.senate.gov and the
individual Member pages
 Due to Congressional mail security systems, they may wish to submit their letter via fax or web form on
individual Members webpages
 If convenient, they may also hand deliver their letter to the Member’s local office (also found on their webpages
or by calling the Washington, D.C. office)
Draft letter to Members of Congress
[DATE]
The Honorable [REPRESENTATIVE/SENATOR]
United States House of Representatives/United States Senate
[# Office] House Office Building [# Office] Senate Office Building
(House) Washington, DC 20515/(Senate) Washington, DC 20510
Dear Congressman/Senator [LAST NAME]:
I am writing you on behalf of the [NUMBER OF EMPLOYEES] employees working here in [CITY, STATE] to deliver [or to
support] the finest and most critical public health paper products made in America. The Food and Drug Administration
(FDA) is taking aggressive action that imperils the livelihoods of every single employee and family working here. We
need your help, right now, please. They need your help!
As you may know, the Federal Food, Drug & Cosmetics Act, passed by Congress, requires all prescription medicines to be
accompanied with printed directions and warnings about conflicts with other medicine and side effects. Our company is
part of the long and robust value chain that provides those printed inserts – the only information accompanying all
drugs that is manufacturer prepared and FDA approved. In 2013, the FDA made notice that it wanted Congressional
authority to replace printed inserts with web-based information. Congress answered in a clear voice: permission denied!
The 2013 Drug Quality and Security Act was passed after striking out the FDA’s requested change. Furthermore, the FY
2015 “Cromnibus”, passed by Congress and signed by the President, contained specific language regarding this matter,
found in the Senate Report of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Appropriations Act, and approved by the House and Senate.
The Senate report, in part, reads:
The Committee is aware that FDA is considering regulatory changes that could eliminate printed
professional inserts for prescription drugs. A July 2013 GAO report on the topic concluded that while there
were potential health benefits associated with electronic labeling, relying exclusively on electronic
labeling could disadvantage physicians, pharmacists, other healthcare providers, and ultimately patients,
potentially adversely impacting public health. Therefore, the Committee directs FDA to ensure that any
proposed regulation regarding electronic inserts of drug labeling does not come in lieu of paper inserts.
(Emphasis added).
Nonetheless, on December 18, 2014, as Congress was rejoining their families for the holidays, the FDA posted a Notice
of Proposed Rulemaking, entitled, “Electronic Distribution of Prescribing Information for Human Prescription Drugs,
Including Biological Products.”
Contained within this proposed rule is:
“prescribing information intended for health care professionals will no longer be permitted to be
distributed in paper form with the package from which a prescription drug or biological product is
dispensed.” (Emphasis added).
It is our long-time understanding that Congress wrote the law requiring paper inserts for a multitude of sound reasons.
Among them:



The pharmacist has the information, literally, at his or her fingertips when it’s needed, without interrupting
workflow.
It’s hack-proof. We only need to look back as far as last week to see that Anthem was brutalized by hackers and
patient data was put at risk. How can pharmacies be assured that the information they see is not counterfeit?
They cannot.
The pharmaceutical manufacturers are better able to handle, and should be responsible for, the costs related to
distributing information about their product, rather than shifting it to local pharmacists, which this rule would
do immediately.
FDA fails to articulate that there is a current problem that this rule would fix. FDA admits this in the proposed rule, “The
public health benefits of users having access to the most up-to-date version of the prescribing information have not
been quantified.” If there were a problem, wouldn’t FDA be able to demonstrate the benefits?
We realize that [CITY, STATE] is a long way from Capitol Hill, but your immediate assistance is appreciated. Specifically,
are you willing to contact the FDA Commissioner and explain that Congress has the authority, Congress denied the FDA
the authority, and the FDA should remedy the situation immediately by withdrawing their proposed rule? Or, would you
be willing to post comments to the rule docket, expressing your displeasure this this rule and explaining that in this case,
printed, paper inserts must continue to accompany ALL prescription drug products to ensure 100% access to this critical
information?
We are grateful for your attention and consideration of this important request for assistance. Please feel free to reach
me directly or Bob Brooks or Amanda Powers at our Pharmaceutical Printed Literature Association (PPLA) government
relations office, at (202) 543-3383.
Sincerely,
[NAME/TITLE]
Draft letter to Members of Congress
[DATE]
The Honorable [REPRESENTATIVE/SENATOR]
United States House of Representatives/United States Senate
[# Office] House Office Building [# Office] Senate Office Building
(House) Washington, DC 20515/(Senate) Washington, DC 20510
Dear Congressman/Senator [LAST NAME]:
I am writing you on behalf of [COMPANY] in [CITY/STATE]. We supply [or supply support for] important printed
prescription drug information that accompanies the drug product from the manufacturers to dispensing sites
nationwide. The Food and Drug Administration (FDA) is taking drastic action against the very product we produce which
will have devastating consequences to the [NUMBER] employees working here. We are asking for your help.
Congress passed the Food, Drug, and Cosmetics Act requiring printed directions for use and warnings accompany all
prescription drugs on or within the product packaging. By producing these inserts, we believe we are providing a critical,
potentially lifesaving, service to American patients.
In 2013, FDA made an appeal for Congressional authority to replace the printed inserts we produce [or support] with
electronic information. The Drug Quality and Security Act passed after Congress specifically excluded the requested
authority. If that was not clear enough, the FY 2015 omnibus appropriations bill contained language referring to this
issue in the Senate Report of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Appropriations Act, which was approved by both chambers and signed by the President.
The Senate report states:
The Committee is aware that FDA is considering regulatory changes that could eliminate printed
professional inserts for prescription drugs. A July 2013 GAO report on the topic concluded that while there
were potential health benefits associated with electronic labeling, relying exclusively on electronic
labeling could disadvantage physicians, pharmacists, other healthcare providers, and ultimately patients,
potentially adversely impacting public health. Therefore, the Committee directs FDA to ensure that any
proposed regulation regarding electronic inserts of drug labeling does not come in lieu of paper inserts.
(Emphasis added).
In spite of these Congressional actions, on December 18, 2014, as the holiday break was about to get underway, the FDA
posted a Notice fore Proposed Rulemaking, entitled “Electronic Distribution of Prescribing Information for Human
Prescription Drugs, Including Biological Products” for publication in the Federal Register.
This proposed rule reads in part:
“prescribing information intended for health care professionals will no longer be permitted to be
distributed in paper form with the package from which a prescription drug or biological product is
dispensed.” (Emphasis added).
We believe that Congress mandated printed paper inserts for many reasons, including:

Pharmacists needing this information will have it at their fingertips, without interruptions to their workflow.


The information is safe from nefarious alteration. There have been too many cases lately of hackers wreaking
havoc on the public (most currently with the hack of Anthem). How can FDA guarantee that the information
sought out by the pharmacist is not altered in any way or that malicious malware is not uploaded onto their
systems which could compromise patient information? They can’t.
It should be the responsibility of the pharmaceutical manufacturers to bear the cost of distributing information
with their products, NOT the pharmacists as this rule proposes.
FDA fails to articulate that there is a current problem that this rule would fix. FDA admits this in the proposed rule, “The
public health benefits of users having access to the most up-to-date version of the prescribing information have not
been quantified.” If there were a problem, wouldn’t FDA be able to demonstrate the benefits?
As stated previously, this proposed rule threatens the very existence of our company and the local jobs we provide in
[CITY, STATE], and your immediate assistance would be greatly appreciated. We are asking that you please reach out to
the FDA Commissioner and explain that they do not have the authority to make this change, Congress specifically denied
FDA the authority to do so, and they should withdraw the rule from the Federal Register immediately. We also ask that
you post comments to the rule docket, expressing your displeasure this this rule and explaining that in this case, printed,
paper inserts must continue to accompany ALL prescription drug products to ensure 100% access to this critical
information.
We thank you for your time and attention to the matter and your consideration of our request. Please feel free to reach
out to me or to Bob Brooks or Amanda Powers at our Pharmaceutical Printed Literature Association (PPLA) government
relations office, at (202) 543-3383.
Sincerely,
[NAME/TITLE]
Draft letter to Members of Congress (new to Congress or our outreach)
[DATE]
The Honorable [REPRESENTATIVE/SENATOR]
United States House of Representatives/United States Senate
[# Office] House Office Building [# Office] Senate Office Building
(House) Washington, DC 20515/(Senate) Washington, DC 20510
Dear Congressman/Senator [LAST NAME]:
I am writing you on behalf of [COMPANY] in [CITY/STATE]. We supply [or supply support for] important printed
prescription drug information that accompanies the drug product from the manufacturers to dispensing sites
nationwide. The Food and Drug Administration (FDA) is taking drastic action against the very product we produce which
will have devastating consequences to the [NUMBER] employees working here. We are asking for your help.
On December 18, 2014, the Food and Drug Administration (FDA) posted a Notice of Proposed Rulemaking entitled,
“Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products”, in the
Federal Register. The rule would require that the prescribing information (also known as the package insert, professional
labeling, content of labeling, physician labeling, etc.) –the very product we supply [or support] – that is intended for
health care professionals will no longer be permitted to be distributed in paper form with the package from which a
prescription drug or biological product is dispensed.
In other words, the package would include a statement directing the health care professional (mainly the pharmacist) to
an FDA web site repository to search/access the information or to call an 800-number managed by the drug
manufacturer and request that a copy be emailed, faxed, or mailed to the professional.
FDA’s only justification for proposing this rule so the “most current prescribing information for distributed prescription
drugs will be available and readily assessable to health care professionals at the time of clinical decision making and
dispensing”. If the website repository is unavailable to the professional for any reason (internet/power outage, slow
connection, etc.), they can either call the manufacturer for an emailed, faxed, or mailed copy or possibly utilize 3rd party
electronic or paper compendia (example, PDR). These methods could prove to be completely inadequate depending on
the reason for lack of access. Email, fax, and mail are not always viable options and could delay or could result in adverse
events experienced by patients.
Not only would this rule have a negative impact on business, but it is also not in the best interest of public health and
safety, and FDA lacks the statutory authority to enact it. Congress passed the Food, Drug, and Cosmetics Act requiring
printed directions for use and warnings accompany all prescription drugs on or within the product packaging. By
producing these inserts, we believe we are providing a critical, potentially lifesaving, service to American patients.
In 2013, the FDA made notice that it wanted Congressional authority to replace printed inserts with web-based
information. Congress answered in a clear voice: permission denied! The 2013 Drug Quality and Security Act was passed
after striking out the FDA’s requested change. Furthermore, the FY 2015 “Cromnibus”, passed by Congress and signed by
the President, contained specific language regarding this matter, found in the Senate Report of the Agriculture, Rural
Development, Food and Drug Administration, and Related Agencies Appropriations Act, and approved by the House and
Senate.
The Senate report, in part, reads:
The Committee is aware that FDA is considering regulatory changes that could eliminate printed
professional inserts for prescription drugs. A July 2013 GAO report on the topic concluded that while there
were potential health benefits associated with electronic labeling, relying exclusively on electronic
labeling could disadvantage physicians, pharmacists, other healthcare providers, and ultimately patients,
potentially adversely impacting public health. Therefore, the Committee directs FDA to ensure that any
proposed regulation regarding electronic inserts of drug labeling does not come in lieu of paper inserts.
(Emphasis added).
We believe that Congress mandated printed paper inserts for many reasons, including:



Pharmacists needing this information will have it at their fingertips, without interruptions to their workflow.
The information is safe from nefarious alteration. There have been too many cases lately of hackers wreaking
havoc on the public (most currently with the hack of Anthem). How can FDA guarantee that the information
sought out by the pharmacist is not altered in any way or that malicious malware is not uploaded onto their
systems which could compromise patient information? They can’t.
It should be the responsibility of the pharmaceutical manufacturers to bear the cost of distributing information
with their products, NOT the pharmacists as this rule proposes.
FDA fails to articulate that there is a current problem that this rule would fix. FDA admits this in the proposed rule, “The
public health benefits of users having access to the most up-to-date version of the prescribing information have not
been quantified.” If there were a problem, wouldn’t FDA be able to demonstrate the benefits?
As stated previously, this proposed rule threatens the very existence of our company and the local jobs we provide in
[CITY, STATE], and your immediate assistance would be greatly appreciated. We are asking that you please reach out to
the FDA Commissioner and explain that they do not have the authority to make this change, Congress specifically denied
FDA the authority to do so, and they should withdraw the rule from the Federal Register immediately. We also ask that
you post comments to the rule docket, expressing your displeasure this this rule and explaining that in this case, printed,
paper inserts must continue to accompany ALL prescription drug products to ensure 100% access to this critical
information.
We thank you for your time and attention to the matter and your consideration of our request. Please feel free to reach
out to me or to Bob Brooks or Amanda Powers at our Pharmaceutical Printed Literature Association (PPLA) government
relations office, at (202) 543-3383.
Sincerely,
[NAME/TITLE]
Draft letter to Members of Congress for employees, friends, family, etc.
[DATE]
The Honorable [REPRESENTATIVE/SENATOR]
United States House of Representatives/United States Senate
[# Office] House Office Building [# Office] Senate Office Building
(House) Washington, DC 20515/(Senate) Washington, DC 20510
Dear Congressman/Senator [LAST NAME]:
My name is [NAME] and I am a resident of [CITY/TOWN/COUNTY]. I am writing to you as a concerned citizen about a
regulation proposed by the Food and Drug Administration (FDA).
On December 18, 2014, the FDA posted a Notice of Proposed Rulemaking entitled, “Electronic Distribution of Prescribing
Information for Human Prescription Drugs, Including Biological Products”, in the Federal Register. The rule would require
that the prescribing information that is intended for health care professionals will no longer be permitted to be
distributed in paper form with the package from which a prescription drug or biological product is dispensed.
In other words, the package would include a statement directing the health care professional (mainly the pharmacist) to
an FDA web site repository to search/access the information or to call an 800-number managed by the drug
manufacturer and request that a copy be emailed, faxed, or mailed to the professional.
As a patient, this deeply troubles me. I ask for this information from my pharmacist, and like to know that it is
accompanying the very product I am being prescribed. I believe pharmacists and other health care professionals need
this information at their fingertips – without interruption to the services they provide. If a website repository is
unavailable for any reason (internet/power outage, slow connection, etc.), the methods for accessing the information
could prove to be completely inadequate depending on the reason for lack of access. Email, fax, and mail are not always
viable options and could delay treatment (and therefore, relief) or could even result in adverse events.
Also, the information needs to be safe from malicious alteration. There have been too many cases lately of hackers
wreaking havoc on the public, most currently with the hack of Anthem. The security of not only the prescribing
information, but also confidential patient health information needs to be given the upmost priority, something FDA has
failed to do. Drug manufacturers must be responsible for distributing information WITH their products, and it should not
be the pharmacists, other health care professionals, or patients who assume the cost, or burden, of accessing this critical
information.
Your immediate assistance would be greatly appreciated. I am asking that you please reach out to the FDA
Commissioner and explain that this rule is NOT in the best interest of patients, and they should withdraw the rule from
the Federal Register immediately. I also ask that you post comments to the rule docket, expressing your displeasure this
this ill-advised rule and explaining that in this case, printed, paper inserts must continue to accompany ALL prescription
drug products to ensure 100% access to this critical information.
Thank you for your time and attention to the matter and your consideration of my request.
Sincerely,
[NAME]
Supporting Bullet Points
 The Rule:




Prescribing information intended for health care professionals will no longer be permitted to be distributed in
paper form with the package from which a prescription drug or biological product is dispensed
 Prescribing information = ALL of the information about a prescription drug product utilized by health care
professionals to determine clinical treatment decisions
 Contains: indications and usage, dosage and administration, contraindications, warnings, adverse reactions,
interactions and precautions, etc.
Drug packages would include a statement directing the health care professional (mainly pharmacists) to an FDA
website repository to search/access the information or to call an 800-number managed by the drug
manufacturer and request a copy be emailed, faxed, or mailed to the professional
Benefits/savings would be seen by drug manufacturers (by not having to supply the printed copy with the
package)
Costs would be incurred by pharmacies
 To access the information (internet access, additional computer terminals, systems security, etc.)
 Increased search time when accessing the information (more time to search for information, less time to fill
prescriptions and counsel patients)
 Printing costs when a request is received for the information in printed form (additional printers, supplies,
time to possibly switch paper, etc.)
 Problems with proposed rule:

Drug manufacturers should be responsible for supplying information that can be accessed 100% of the time,
24/7/365

Potential issues with accessing the information
 Some pharmacies currently have no or limited internet access
 Possible loss of internet connectivity and/or slow internet connections
 If cannot access, additional references may not be available as well depending on the nature of the access
loss
 If call the manufacturer to request info, email and/or fax might not be an option, and mail would take
too long
 Emails could be sent to the wrong address or do not have access to email at pharmacy
 Faxes could jam, errors can result, and incomplete information could be received
 Potential issues switching between various pharmacy software
 What if cannot access?
 Withhold medications? Distribute without verifying information?

Disruptions to pharmacy workflow
 Increased time to switch between various pharmacy systems and/or search time
 Interruptions to workflow decreases time available to counsel patients (GAO report, page 13)
 Interruptions to workflow have been shown to increase the risk for errors made when dispensing a drug
(GAO report, page 13)

Instructions for administering, assembling, reconstituting, mixing, diluting, or other preparations done prior to
dispensing to a product to a patient


Critical information that needs to ALWAYS accompany the physical product to ensure 100% access to avoid
potential errors
Cybersecurity Issues
 Many stories on the news regarding attacks against Federal agency websites and systems
 What is FDA’s plan for guaranteeing absolute security of the information?
 Health practice systems contain patient’s sensitive, personal, and confidential health information
 Opening systems to the internet could allow intrusions by nefarious actors
 Liability if information is compromised and used?
 The paper insert cannot be hacked and improperly changed
 FDA Lacks Statutory Authority


Drug label must be “written, printed, or graphic matter” and “upon the immediate container” (21 USC 321 (k)
and (m))
Misbranded unless labeling bears adequate directions for use and adequate warnings (21 USC 352 (f))
 FDA has not calculated the costs or benefits to public health
 In the “Costs and Benefits” section:
 “The public health benefits of users having access to the most up-to-date version of the prescribing
information have not been quantified.”
 If there is a current “problem” that this rule is “fixing”, shouldn’t it be easy to calculate “savings”?
 This is a solution in search of a problem.
 And patients will pay.
United States Government Accountability Office
Electronic Drug Labeling: No Consensus on the Advantages and Disadvantages of Its Exclusive Use
July 2013
GAO-13-592
Link to full report: http://www.gao.gov/products/GAO-13-592
Key Findings with Regard to Patient Safety:
GAO findings

The GAO states, “Relying on electronic labeling as a complete substitute for paper labeling could adversely
impact public health by limiting the availability of drug labeling for some physicians, pharmacists, and patients
by requiring them to access drug labeling through a medium with which they might be uncomfortable, that they
might find inconvenient, or that might be unavailable. (GAO, What GAO Found & page 10)

The GAO reported, “We found no consensus among stakeholders on the advantages and disadvantages of
eliminating paper labeling and relying instead on electronic labeling as a complete substitute for paper labeling”
(GAO, page 8).

The GAO report mentioned possible electronic advantages. However, the report further stated “…noted
disadvantages that could offset advantages gained from relying on electronic drug labeling as a complete
substitute for paper labeling” (GAO, page 8 & 10).
Overall Access

GAO noted, “In certain situations, the availability of technology is limited”, especially “areas with limited
internet access, such as rural areas” (according to a Federal Communications Commission study, 14 million
Americans have inadequate access or no access to adequate broadband capabilities) and “times when such
technology is simply not available, due to temporary power outages or during the aftermath of natural disasters,
such as Hurricanes Sandy and Katrina” (GAO, page 11).
Physicians

GAO referenced an Institute of Medicine report finding that “the way in which drug information is
communicated to physicians can directly affect their knowledge of how the drugs they are prescribing will
work in patients, particularly in specific populations, such as children and the elderly” (GAO, page 1).

Physicians, might “require additional training on where and how to access prescribing information electronically.
Studies have shown that physicians might not access the most reliable resources on the Internet in order to find
the information they need”. Specifically, GAO sourced a study in The Journal of the Medical Library Association
which found that “in some cases, physicians based clinical decisions on websites that ranked lower than other
sources in measures such as reliability and relevance” (GAO, page 12).

Also, GAO cited an American Medical Informatics study found that “the websites used by emergency room staff,
residents, and medical students to obtain clinical information were not the highest quality in terms of evidencebased medicine” (GAO, page 12).
Pharmacies/pharmacists

In 2011, retail pharmacies filled approximately 3.8 billion prescriptions for drugs (GAO, What GAO Found & page
15).

GAO highlighted an Institute of Medicine report which found that “drug information communicated to
pharmacists is critical to helping them appropriately fill prescriptions and to check for potential safety concerns
for a specific patient” (GAO, page 1).

Pharmacists said they “are familiar with using paper labeling,” and they find it “easier, when counseling
patients, to take the paper version of the labeling directly from the drug packaging and show it to the patient at
the counter rather than searching for the labeling on a computer and then showing the patient the computer
monitor or printing the labeling” (GAO, page 13).

A study from The Annals of Pharmacotherapy and noted by GAO found that if “pharmacists’ workflow is
disrupted because they need to print drug labeling for patients, it could reduce the time available for patient
consultations” and the previously mentioned Institute of Medicine report showed “interruptions to pharmacists’
workflow have been shown to increase the risk for errors made when dispensing a drug” (GAO, page 13).

Moreover, “pharmacies said that most pharmacies, in order to protect their systems from potential threats like
computer viruses, do not have Internet access” (GAO, page 15).

A shift in responsibility from the drug manufacturer to pharmacies would result in pharmacies needing to
“purchase additional resources, such as computer terminals, printers, and other office supplies, such as paper,
ink, and toner” (GAO, page 15).