Life Science Compliance Update

August 07, 2017

AbbVie Found Liable for Misrepresentation in AndroGel Case


In July 2017, a Chicago jury found AbbVie Inc. guilty of fraudulently misrepresenting the risks of its testosterone replacement drug AndroGel. The federal jury ordered the company to pay $150 million in punitive damages.


The verdict comes in a case where Jesse Mitchell blamed the drug for a heart attack he had in 2012 after four years of taking AndroGel. Mitchell, who used AndroGel from 2008 to 2012, alleged that AbbVie knew or should have known the drug could cause cardiovascular disease, strokes and other serious injuries, but failed to adequately warn consumers and doctors. He was 49 at the time of his heart attack.

He took the drug during an active advertising campaign warning consumers about "low T." The company marketed the drug to consumers despite its "dangerous side effects" even though there were "safer alternative methods of treating loss of energy, libido erectile dysfunction, depression, loss of muscle mass and other conditions AndroGel's advertising claims are caused by low testosterone," Mitchell alleged in court documents.

The company had argued in court documents that Mitchell had other risk factors that could have caused his heart attack, such as a history of smoking, high blood pressure and high cholesterol, among other things.

Jury Decision

The jury did note that AbbVie was not negligent or strictly liable for the heart attack Mitchell suffered after taking AndroGel, but that nonetheless, AbbVie falsely marketed the drug. The jury, however, found in favor of AbbVie on allegations that AndroGel lacked adequate warnings or instructions, making it unreasonably dangerous, as well as allegations that the company was negligent.

Mitchell also sought compensatory damages for his injuries and losses. It is interesting that the jury determined that AndroGel did not cause any damage, but nonetheless awarded punitive damages.

The decision is the first in a series of test cases that are aimed at helping plaintiffs (and the makers of AndroGel) gauge the range of damages so they can craft a legal strategy and settlement options going forward. The verdict – in response to a lawsuit filed by Jesse Mitchell and his wife in 2014 – is the first in response to more than 6,000 pending lawsuits that have been consolidated in federal court in Chicago.

Statements and Analysis

"The jury found that AndroGel did not cause any damage," AbbVie said in a statement. The company said that it did not expect the punitive damage award to stand, without providing further details.

Carl Tobias, a law professor at the University of Richmond, said the jury's decision to award punitive damages without granting compensatory damages was "extremely unusual."

"Usually you can't recover punitive damages without having any compensatory damages," Tobias said. Even still, he believes that, "The fact that a jury awarded punitive damages may encourage plaintiffs and their lawyers to bring on more cases and pursue them even more aggressively."

Even with the likelihood of AbbVie appealing, it is still newsworthy as the settlement is likely to have an impact on the outstanding cases with similar fact patterns.

March 31, 2017

CDER 2017 Guidance Agenda


In January, FDA’s Center for Drug Evaluation and Research (CDER) released its annual guidance agenda, announcing the new and revised draft guidances that the Center plans to publish during the 2017 calendar year. CDER’s 102-part agenda is organized by category and touches on a variety of topics, giving us a glimpse of what to expect throughout the year. This year’s agenda follows a similar pattern to the Center’s 2016 agenda, placing an emphasis on the clinical aspects of drug development, pharmaceutical quality, generics, and procedural activities. However, CDER is not bound by this list of topics, required to issue a guidance on every topic included in the list, or precluded from developing guidance on topics not included in the list. According to Regulatory Focus, several items on the 2017 list were also listed in 2016.

Delayed by Trump Executive Order?

Maybe, but it is not entirely clear. Additionally, the items in CDER’s announcement reflect only draft and revised draft guidances under development as of the date of FDA's posting. So there is still the potential for modifications, even more potential guidances.

Recent reporting from Regulatory Focus indicates the “Two Out, One In” Executive Order may have been clarified through OMB guidance to offer “wiggle room” for the FDA in issuing guidances. OMB notes that “significant guidance or interpretive documents will be addressed on a case-by-case basis.” Rachel Sachs, an associate law professor at Washington University in St. Louis, argues the OMB document "significantly restricts" and "walks back" the reach of the EO because it exempts classes of regulations required by law and appreciates that regulations may be deregulatory in nature so the costs and issuance of such regulations will be considered accordingly.

“Emergencies addressing critical health, safety, or financial matters, or for some other compelling reason, may qualify for a waiver from some or all of the requirements of Section 2,” the guidance also notes, which may further allow the FDA room to move on these issues.

The 2017 Agenda

A few interesting items that stood out:


  • Drug and Device Manufacturer Communications with Payors, Formulary Committees and Similar Entities


  • Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations; Revised Draft


  • Considerations in Demonstrating Interchangeability With a Reference Product
  • Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity


  • Guidance for clinical Investigators and Sponsors Natural History Studies for Rare Disease Drug Development
  • Pediatric Oncology Product Development; Revised Draft
  • Rare Diseases: Drug Development Safety Data Considerations

Clinical Pharmacology:

  • Clinical Drug Interactions Studies: Study, Design, Data Analysis, Implications for Dosing and Labeling Recommendations, Revised Draft
  • Clinical Lactation Trials – Trial Design, Data Analysis and Recommendations for Labeling; Revised Draft
  • Exposure-Response Relationships – Study Design, Data Analysis, and Regulatory Applications; Revised Draft
  • Population Pharmacokinetics; Revised Draft


  • Adaptive Design Clinical Trials for Drugs and Biologics; Revised Draft
  • Meta-Analysis of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biologic Products

Drug Safety:

  • Format and Content of a REMS Document, Revised Draft
  • Postmarketing Safety Reporting for Human Drugs and Biological Products Including Vaccines, Revised Draft

Electronic Submissions:

  • Standardized Format for Electronic Submissions of NDA and BLA Content and Planning and Conduct of Bioresearch Monitoring Inspections for Submissions to CDER
  • Providing Regulatory Submissions in Electronic Format – Submission of Manufacturing Establishment Information
  • Providing Regulatory Submissions in Electronic Format – Bioanalytical Methods Data Standards
  • Providing Regulatory Submissions in Electronic Format – Standardized Bioanalytical Data


  • 180-Day Exclusivity: Questions and Answers
  • ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA
  • ANDA Submissions – Content and Format of Abbreviated New Drug Applications; Revised Draft
  • ANDA Submissions Refuse to Receive Standards: Questions and Answers
  • Controlled Correspondence Related to Generic Drug Development; Revised Draft
  • Changes That May Be Included in a Single Prior Approval Supplement for an ANDA
  • Determining Whether To Submit an Application Under 505(b)(2) or 505(j)
  • Issuance of ANDA Complete Response Letters Before Completion of Review by One or More Disciplines
  • Meetings With Applicants of Complex Generic Drug Products
  • Pre Submission Facility Correspondence for Priority ANDAs in GDUFA II
  • Three-Year Exclusivity Determinations for Drug Products
  • Variations in Drug Products (ANDAs) Guidance


  • Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products – Content and Format
  • Indications and Usage Section of Labeling for Human Prescription Drugs and Biological Products – Content and Format

Pharmaceutical Quality/CMC:

  • GDUFA II Priority ANDA Pre-Submission Communications
  • Harmonizing Compendial Standards with Drug Application CMC Approval Requirements Using the USP Pending Monograph Process

Pharmaceutical Quality/Manufacturing Standards (CGMP):

  • Current Good Manufacturing Practice for Medical Gases; Revised Draft
  • Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products; Revised Draft


  • Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers
  • Civil Monetary Penalties for Failure to Meet Accelerated Post marketing Requirements
  • Compliance Policy Guide: Marketed Unapproved Drugs Section 440.100; Revised Draft
  • Content of Human Factors Submissions for Evaluation
  • Designated Delivery Services for 505(b)(2) or ANDA Applicants Sending Notices of Paragraph IV Patent Certification
  • Enforcement Policy Regarding Ingredients Nominated for Inclusion on the Bulk Drug Substances List Pursuant to Section 503B
  • Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
  • National Drug Code (NDC) Assignment of CDER-Regulated Products
  • Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations; Revised Draft
  • Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Regulatory Considerations; Revised Draft
  • Public Disclosure of FDA-Sponsored Studies
  • Refuse to File: NDA and BLA Submissions
  • REMS Assessment: Planning and Reporting
  • Standardization of Data and Documentation Practices for Product Tracing
  • Survey Methodologies to Assess Risk Evaluation and Mitigation Strategies (REMS) Goal Related to Knowledge
  • Use of a Drug Master File for Shared System Risk Evaluation and Mitigation Strategies (REMS)
  • Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs

User Fees:

  • User Fee Waivers, Reductions, and Refunds for Drug and Biological Products
  • Fees Incurred Under the Drug Supply Chain Security Act

February 28, 2017

Trump Executive Order Targets Regulations


On one of his first few days on the job, President Donald Trump signed an executive order that would require all government agencies to eliminate two regulations for every one new regulation instituted.

The order was characterized by the Administration as a plan to help benefit small businesses. However, it is likely to have an impact on the United States Food and Drug Administration (FDA) as it applies to every agency (other than those related to military or national security), or any other agencies exempted by the Office of Management and Budget (OMB).

How this plan will work for an agency like the FDA is hard to comprehend: most of the regulations are intertwined with one another. As the EO is written, if the agency needed to put in place a new regulation, it would then have to presumably cut out two other, unrelated regulations that are linked to public health.

Another problem is that, according to the text of the EO, the directions apply to FDA guidance documents as well. This will be a large problem for pharmaceutical and medical device companies that rely on such guidances to understand FDA’s interpretations of the law. The EO defines the term ‘regulation’ or ‘rule’ to mean “an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency.

The way this EO is implemented across the federal government is going to come largely from the OMB director, who will provide the heads of agencies with guidance addressing, among other things, “processes for standardizing the measurement and estimation of regulatory costs; standards for determining what qualifies as new and offsetting regulations; standards for determining the costs of existing regulations that are considered for elimination; processes for accounting for costs in different fiscal years; methods to oversee the issuance of rules with costs offset by savings at different times or different agencies; and emergencies and other circumstances that might justify individual waivers of the requirements.” 

Prior to releasing this EO, President Trump said, “This will be the biggest such act that our country has ever seen. There will be regulation. There will be control. But it will be normalized control where you can open your business and expand your business easily.”

"If you have a regulation you want, No. 1, we're not going to approve it because it's already been approved, probably, in 17 different forms," Trump said from the White House. "But if we do, the only way you have a chance is we have to knock out two regulations for every new regulation."

Although many of Trump's other executive orders have been met with criticism, this latest policy is not unfounded. Back in 2010, the United Kingdom adopted a similar policy, though its implementation did not apply to taxes, certain European Union legislation, non-business regulations and "regulation for civil emergencies," according to the U.K. government.

OMB Issues Guidance

On February 2, 2017, the OMB did issue guidance to the Agencies, highlighting what to expect and how to handle this executive order. The Q&A offers some clarity and boundaries for the EO signed last Monday, noting: “The EO’s requirements for Fiscal Year 2017 apply only to those significant regulatory actions, as defined in Section 3(f) of Executive Order 12866, an agency issues between noon on January 20 and September 30, 2017.”

But the OMB guidance does offer some wiggle room for FDA in terms of issuing draft or final guidance (2017 guidance plans for FDA's Center for Drug Evaluation and Research are here) noting that “significant guidance or interpretive documents will be addressed on a case-by-case basis.”

As far as what existing regulations if repealed would be considered part of the “two out” part of the EO, OMB notes, “Any existing regulatory action that imposes costs and the repeal or revision of which will produce verifiable savings may qualify.”

The guidance also offers FDA, which is an agency that deals with public health and safety, some ways to waive the “two out, one in” requirements of the EO. “Emergencies addressing critical health, safety, or financial matters, or for some other compelling reason, may qualify for a waiver from some or all of the requirements of Section 2,” the guidance notes.

But if a new regulation is implementing a new law from Congress (for instance, with FDA’s pending implementation of the 21st Century Cures Act), OMB clarifies that agencies should still “identify additional regulatory actions to be repealed in order to offset the cost of the new significant regulatory action, even if such action is required by law.”


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