Will the Real FDA Please Stand Up?

Stephen D. TermanPrincipal

Olsson Frank Weeda Terman Matz PC

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Key Take-Aways

• Insights into what’s going on at FDA today

• Examples of new areas of focus for FDA

• Tools to deal with the FDA

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The Old FDA• SLOW

– Approval timing was slow but is better with user fees

– Compliance/enforcement faster, depending on circumstances

• But FAST– At issuing regulations and guidance

• Focus on Globalization – FDA across the globe

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What is the Current Climate inside FDA?

• New Administration– “Old Guard” out

• good or bad? • Regulatory Correction?

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What is the Current Climate Inside FDA?

• Slower to Issue regulations• “Executive Order on Reducing Regulation and Controlling

Regulatory Costs”• Decrease Regulation and Costs: 1 regulation in, 2 out policy• Excludes regulations required by statute

• Executive Order requiring agencies to establish a task force headed by a regulatory reform officer to review existing regulations to meet policy goals.

• Will this be more burdensome for FDA; What will be FDA’s approach?

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What is the Current Climate inside FDA?

Faster on approvals – Trump Policy Process “keeps too many advances… from reaching those in need”-

President Trump Budget and User Fees will impact this

Gottleib to reduce Orphan Drug Designation Request backlog Executive Order freezing new hiring could impact the ability to

implement policy. Possible EO on Drug Pricing will provide more guidance on the

Administration’s policy

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What is the Current Climate Inside FDA?

Globalization has been a priority, but FDA cannot inspect its way to safety and must apply the basic principle of prevention to imports. Better controls at the point of production Hold importing companies responsible for their supply

chain Foreign and domestic regulation and listing Border Protection is enhanced due to security concern Lower threshold for entry refusal

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What’s Going on at FDA Today?

Less enforcement generally since January• Warning letters down

• Only 1 WL issued by OPDP; • 310 WLs issued YTD in 2016 vs. 209 YTD in 2017*

*compares publically available WLs on FDA’s website (and excludes Center for Tobacco WLs).

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What’s Going on at FDA Today?

• But Enforcement was up in 2016• “recall events” are up in 2016 (2,847) compared to 2015 (2,789)• Class 1 recalls for drugs, devices, and foods are up in 2016• 4 seizures in 2016, compared to 1 in 2015

• Enforcement still a moving target with the new administration

• Enforcement: Top 483s Devices: inadequate procedures (complaint, MDR, nonconforming product;

purchasing controls); inadequate process validation; CAPA documentation Drugs: Procedures not written/followed; no scientifically sound lab

controls; failure to investigate discrepancies in batches; deficient environmental monitoring system

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New Areas of Focus for FDA

• FDA once called “the result of American tragedies”

• Media focus becomes FDA focus– Compounding– Opioid abuse – Drug Prices– Infections from endoscopes

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New Areas of Focus for FDA Compounding

Began in 2012 with NECC; Drug Quality and Security Act followed in 2013.

72 “outsourcing facilities” currently registered 109 inspections, Issued more than 150 Warning Letters advising compounders of significant

violations Overseen 125 recalls Civil and criminal enforcement

Enforcement unlikely to slow; New Commissioner issued statement on assuring safety of compounded drugs

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New Areas of Focus for FDA

Opioids True epidemic, affecting many Americans. This issue is

not just being addressed by FDA, but also by DEA, and state medical/pharmacy boards.

FDA deemed Opana ER too dangerous to be on the market; the first time FDA has requested that a company pull its drug “due to the public health consequences of abuse.”

Commissioner Gottlieb – require manufacturers to provide education for physicians that prescribe opioids

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New Areas of Focus for FDA

Drug Prices Issue stemmed from Media

Martin Shkreli Epi Pen price increase

Trump latched on to issue during the election Trump solution is faster approval and less burdensome regulation

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New Areas of Focus for FDA • Possible regulation of device Servicers and

Refurbishers– Triggered by infections caused by dirty

Duodenoscopes – story broken by L.A. Times– Will require more resources for FDA– FDA previously regulated industry– Public Workshops held, comments solicited but no

regulation yet– Draft Legislation to require the agency to regulate

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New Areas of Focus for FDA Outside of Drugs and Devices – FSMA and

Tobacco However, legislative proposal to roll back e-cigarette

regulation; other compliance dates extended

Implementing the 21st Century Cures Act Off-label promotion Caronia, Amgen

Individual responsibility (Park Doctrine) Was gone for a while, but now back

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New Areas of Focus for FDA Globalization Still a priority – All drugs and devices approved/cleared in

the US, must be in compliance FDA requirements (no matter where they are manufactured). Therefore there remains a need for FDA resources abroad (and at the border)

Possible change: FDA may need less resources abroad if FDA begins to recognize

inspections conducted by foreign authorities (under FDASIA(2012))

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How to deal with FDA Understand issue Research applicable history Outline key factors Identify goal(s) Identify audience/decision maker Develop outline of key points Develop support for key points Organize presentation of key points Prepare to present in less time

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How to deal with FDA

Anticipate FDA responses Identify types of speakers Draft agenda for FDA Practice presentation Practice presentation Practice presentation Provide real evidence, not just promises

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Who Do I Talk To?

ODE IDE 510(k) 510(k) modification PMA Combination

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Who Do I Talk To?

CDRH Compliance PMA Inspections FDA 483 QSR MDR Part 806/recall

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Who Do I Talk To? Warning Letter QSR MDR Part 806/recall reporting Seizure Injunction Civil penalties Mandatory recall

Trade Complaint

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Who Do I Talk TO?

Field Offices Form FDA 483 Warning Letter Legal actions Trade complaint

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How High Do I Go In FDA?

Types of FDA personnel to communicate with (CDRH/Field Offices) Responsible/authority Not responsible Hierarchy Low Medium High

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Methods of Communication

E-mail Letter Individual telephone call Conference Call In-person meeting

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Communication Strategy Who should contact FDA? Who should be the company’s primary

spokesperson? Do lawyers help or hurt? How visible should outside consultants and lawyers

be? What role should the CEO/President play? What role should the RA/QA person play?

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Communication Strategy Is it appropriate to bring up non-substantial

matters? Can you have more than one meeting? Is there a cost to having a meeting? How do you decide if you want a meeting? When should you involve OGC? Ombudsman? Commissioner Office?

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Communication Strategy

It is appropriate to go around or above a particular person/position? What works better-honey or vinegar? Do threats really work? What about political pressure?

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Bottom Line

It’s a new day at FDA Different approaches for different people What worked before may not work now Be prepared Have real evidence, not just promises Be honest

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