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How to Establish and Maintain a Good How to Establish and Maintain a Good Working Relationship with all Working Relationship with all

Regulatory AgenciesRegulatory Agencies

Jerome J. Gainer, ASQ Certified GMP Pharmaceutical Professional and ASQ Certified Quality Engineer

Originally Presented at

Pet Industry Advisory National Forum Series

By

Which of these quotes should Which of these quotes should describe your attitude concerning describe your attitude concerning

Regulators and Regulations? Regulators and Regulations?

“A civil servant [in a regulatory agency] is like a broken cannon. It won’t work and you can’t fire it.”

—George S. Patton

OR

“It is bad policy to regulate everything where things may better regulate themselves and can be promoted by private exertion, but it is no less bad policy to let those things alone which can only be promoted by interfering social power.”

—Friedrich List

What is the ultimate authority What is the ultimate authority for Animal Health for Animal Health

Regulations?Regulations? “Let us make man in our image, in our likeness,

and let them rule over the fish of the sea, and the birds of the air, over livestock over all the earth, and over all the creatures that move along the ground.”

–God

Is It Important to Have Good Is It Important to Have Good Relationships with these Agencies?Relationships with these Agencies?

Striving for a great relationship with all regulators should be viewed as a top priority.

Good relationships with all regulatory agencies will avoid the following:

Interruption in profitable activities to satisfy an agency Delays in approval of new products Failure to achieve approval of new products Market withdrawals for registration issues Recalls, lost of reputation for quality Loss of market share, devaluation of stock price Failure to meet company goals, loss of bonus opportunity

How Do You Know When Your How Do You Know When Your Company Has Achieved Great Company Has Achieved Great

Regulator Relationships?Regulator Relationships?

Goals and progress toward goals requiring regulatory agency assistance or approval are being met.

Your requests to agencies (such as more time to respond) are being granted.

Without prompting, agency offers to assist you. Company is fully compliant with regulatory requirements.

Regulatory Agencies We Deal with in Regulatory Agencies We Deal with in Animal HealthAnimal Health

Center for Veterinary Medicine (part of FDA) US Federal Trade Commission US EPA (Environmental Protection Agency) USPTO (Patent and Trademark Office) DEA (Drug Enforcement Agency) VDD (Canadian equivalent of CVM) MHRA (English equivalent of FDA) Your state food and drug agency

Regulatory Agencies in Animal Regulatory Agencies in Animal HealthHealth

Your state board of pharmacy Local city environmental agencies Office quebecois de la langue francaise (Quebec language

police) Various industry groups such as AAFCO and National

Animal Supplement Council

What Specifics Do I Need to Know What Specifics Do I Need to Know about Each Agency?about Each Agency?

What are this agency’s “hot button” issues? What power/affect can they have on my business? What reoccurring submissions/documents must be

prepared? What routine/extraordinary cost can I expect? What level of trust have I built with this agency? How can I get a yes to my request/submission? How can I stay off of their problems list?

Hot Button IssuesHot Button Issues

Center for Veterinary Medicine Recalls Illegal advertising and promotion Misbranded labels Unprofessional new drug applications

Hot Button IssuesHot Button Issues

Center for Veterinary Medicine Quality system failures in GMP inspections (483’s) Failure to submit post approval documents (MCSR) Disrespect of agency employees Outright fraud

Hot Button IssuesHot Button Issues

Environmental Protection Agency Failure to submit Quarterly Pharmacovilgilence EPA report on quantity of pesticide manufactured Changes to EPA approved labels Failure to respond to Data Call-in Request

Hot Button IssuesHot Button Issues

Environmental Protection Agency Failure to follow up on PR notices Failure to register a plant that makes any part of a

FIFRA product Performing EPA testing in non GLP facility Making changes to Confidential Statement of

Formula

Hot Button IssuesHot Button Issues

Veterinary Drug Directorate (Canada CVM) Not maintaining GMP compliance of US

manufacturing site (Not able to register facility) Unacceptable French Language translation Failure to establish a QA release operations on

Canadian soil (for DIN products) Importance of documents (as VDD audit will be be

conducted in Canada even if plant is in USA) Preparing a thorough Site Master File Import issues

Hot Button IssuesHot Button Issues

MHRA (English equivalent of FDA) Poor outcome of on site inspection concerning:

– Facilities– Changes– Quality Issues (critical deficiencies)

Poorly prepared site master file Inaccurate/late compliance report (questionnaire) Batch to batch variations Failure to submit updates Failure to follow up on previous deficiencies

Hot Button IssuesHot Button Issues

State Boards of Pharmacy License required for manufacturer/distributor of

prescription animal drugs Inspection of the manufacturing/distribution site for

– General Sanitation– Temperature history in storage area vs label– Expiration date of drugs– DEA security– Invoice matching– Overall security of site and drugs from

pilfering/theft

Things to Do to Establish/Maintain Things to Do to Establish/Maintain Great Regulator RelationshipsGreat Regulator Relationships

Demonstrate competence in verbal and written communications.

Provide supporting documentation for any claims. Strive to be clear, scientifically justifiable, logical, and

well organized in written communication. Take advantage of meeting regulators at stakeholder

meetings and other venues.

Things to Do to Establish/Maintain Things to Do to Establish/Maintain Great Regulator RelationshipsGreat Regulator Relationships

Demonstrate familiarity with challenges that your regulator may have when speaking with them.

Respect and utilize the expertise of your regulator when needed.

Be honest in all your documentation, and do not try to hide obvious problems. Instead show them how you propose to/ or have corrected the problem.

Express appreciation and respect to regulators for help they give.

Things to Do to Establish/Maintain Things to Do to Establish/Maintain Great Regulator RelationshipsGreat Regulator Relationships

Be holistic in correcting a problem. Do not just correct the one instance that the regulator pointed out to you.

Become familiar with guidance documents. Clarify the regulators question before you try to answer it. Give full, complete and truthful responses to the exact

question that is asked. Keep an accurate and complete record of communications

with regulators.

Things to Do to Maintain Great Things to Do to Maintain Great Regulator RelationshipsRegulator Relationships

Pick your battles carefully. Do recognize that although guidance and statues may

appear to be written in stone, good science and logic can prevail.

Maintain a good record with regulators.– Respond by due dates or request more time. – Provide quality professional work.

Strive for win/win solutions. Clear up misunderstandings and summarize discussions.

Things Not to Do to Maintain Great Things Not to Do to Maintain Great Regulator RelationshipsRegulator Relationships

Don’t refer to regulators as just “bureaucrats” or provoke them with hostile comments.

Don’t provoke regulators in written communications by offensives words, unnecessary bolding or capitalization.

Don’t disrespect agency employees regardless of race, gender, or religion.

Don’t be afraid to ask for what you want—but try to supply them with logical, scientifically based reasons why they should agree.

How to Establish and Maintain a How to Establish and Maintain a Great Working Relationship with All Great Working Relationship with All

Regulatory AgenciesRegulatory Agencies

Questions? Questions? Questions?