Open communications key in building trust and collaboration; it will happen one person at a time.

Jackie Torfin, Global Director, NAMSA, shared her perspectives on reinventing collaborations with government in her Wednesday morning session at Aurora WDC’s intelligence leadership symposium.

Her talk focused on how to be innovative in approaching a problem and how her experiences in working with the FDA have reinvented collaboration.

The FDA mission is to protect public health, and the medical and food supplies are regulated via the FD&C Act. Typical contacts with those in industry would be:

  • Submission of product information for review and approval
  • Formal review meetings
  • Public meetings on selected topics
  • Regulation/guidance document public review process

Communications with the regulator are very formal—notarized letters, special portals, and communication is almost always one-way. Very rarely is there an actual conversation.

Enforcement and compliance is important at FDA:

  • Inspections are adversarial—there are websites dedicated to “how to manage an FDA inspection”
  • Submission reviews are routinely stopped/delayed for questions
  • Enforcement types are warning letters, consent decrees, debarment, civil and criminal prosecutions, and product seizures/injunctions/recalls (product quality)

Case studies provide interesting examples.

Case 1: Baxter Healthcare Jan 2017 settlement with the US government. (Criminal charges are no longer rare).

  • $18 million to resolve a False Claims Act suit and bypass criminal charges: Civil settlement amount was small ($2.158 million)
  • They were cited with lack of GMP (good manufacturing practice) compliance under the False Claims Act
  • It arose from an employee complaint about “whether 5 of 120 of these filters needed replacement”
  • There were no out of specification results noted at any time (In product or the environment)

Why did Baxter agree?

  • 2008 episode involving tainted heparin from China?
  • $500 million settlement between India’s Ranbaxy and the FDA in 2013 for GMP violations?
  • But there were no allegation that the company attempted to deceive the FDA as there was with Ranbaxy

Case 2: Howard Root/Vascular Solutions settled a whistleblower civil case without admission of liability.

  • Dept of Justice and US Attorneys Office pursued Mr. Root and the company on criminal charges of selling an adulterated and misbranded medical device and conspiracy
  • The company defended by maintaining the use was on-label, and that even if it wasn’t, their client had the 1st Amendment right to provide truthful information about that use
  • Vascular Solutions was trying to obtain FDA clearance to specifically add the ‘perforator vein’ to labeling of their VARIA-LASE product even though it was already encompassed by the general intended us statement
  • The FDA reviewer, who was new to FDA, demanded clinical work when it wasn’t required so Vascular Solutions withdrew their submission
  • There were no allegations of patient injury
  • FDA and Howard Root never had a conversation about anything prior to charges being brought
  • Defense successfully fought case using FDA’s own guidance documents and cross-examining the prosecution’s own witness
  • Company never called one witness because the government’s witnesses proved the company’s theory
  • The jury brought in a unanimous verdict acquitting both the CEO and company
  • A typical FDA warning letter will have a specific process: A form is issued when part of the regulation is not in compliance. The company responds via letter within 15 days. FDA reviews the response (no acknowledgement). The company responds to warning letter in 15 days. FDA will acknowledge receipt, if they like it you hear nothing, if they don’t like it…??? Seizure injunction, etc.

Product recalls are for safety or quality issues; the company issues a recall, FDA concurs or increases the severity, product sales are stopped, and product is brought back from the field.

Is compliance or product quality the focus?

Compliance activity has increased, but there has not been a correlation with product quality.

Changing the approach to a case for quality is the goal.

McKinsey analyzed device quality issues; there can be improved product quality for the benefit of patients by enhancing product design and manufacturing processes; better information on regulatory practices; and changing the nature of interactions between FDA and industry in relation to quality and compliance.

To change, there has to be collaboration between companies and the FDA. The objective is for FDA to increase transparency.

Today, the “case for quality” is in process. An FDA objective is to implement the Maturity Model, which is about giving the company a tool to assess their level of maturity in meeting regulations.

Some goals in collaboration include collaboration, transparency, culture, realignment, safety, and trust.

Why not have the companies and FDA work together?

The approach should be to include all players–insurance companies, hospital purchasing organizations and others that need information to make a buying decision. A culture of quality will be important.

Medical device reports can be made by anyone; by law, companies need to investigate all claims, whether it was true or not. Filters, then, are necessary.

Quality system elements are assessed to be from level 1-5. An assessment is done in conjunction with the FDA—it is NOT an inspection. Implementation takes time and money and carries a potential level of risk.

A concern is that publication of a company’s maturity levels will be of interest to the competition, and, the FDA will be inclined to enforce rather than collaborate to meet quality standards.

Work to improve the collaboration is ongoing. Topics of discussion include: Reduced pre-market inspections and surveillance inspections, reeducated enforcements, increased collaboration and partnership when issues are identified so it will not immediately escalate to enforcement. Accelerated time to market is a goal, another is that self-reported issues will not result in regulatory action if a trusted third party is engaged to support remediation.

Ultimately, the hope is for decreased inspections with increases in product quality; more informal communications; a partnership to look for solutions rather than for enforcement opportunities; and better information exchanges.

One example of change: A recent FDA inspection discovered several deficiencies in relation to deviations and investigations in a particular company–an inspector identified a 483 violation. (Training that the company receives is to share as little information as possible and do not affirm the issue or finding).

The company representative, rather than keeping silent, opened the dialogue. Other company employees became uncomfortable in this person’s transparency. But nonetheless, the speaker reviewed the history, outlined a plan for improvement, and asked for feedback.

The outcome was the inspector and that person made a commitment to improve the process—no 483 was assessed.