FDC Reports and Sidley Austin proudly present:

REMS: The New FDA Post-Market Safety Restrictions for Drugs…
AND Devices

Presented by:




 


Thursday, Nov. 13, 2008 • 12 PM ET / 9 AM PT • 90 minutes
About the event • Key topics • Who should attend • Speakers
• Benefits • Register

Featuring

Coleen Klasmeier
Partner
Sidley Austin LLP

Lauren Silvis
Associate
Sidley Austin LLP

Michael McCaughan
Editor-In-Chief
FDC Reports
Biopharma Group
(Moderator)

Live webinar: $399
Live webinar plus complete audio recording: $499
Audio recording only: $499

New legislation intended to help protect patients from undue risks associated with medical products provided the FDA with strengthened post-marketing drug safety oversight. The law allows the FDA to require that sponsors submit Risk Evaluation and Mitigation Strategies (REMS) to ensure that the benefits of the drug outweigh the risks. So far, implementation and interpretation of the law has not been without problems. Now some in CDRH are asserting REMS-like powers for devices. Find out how the FDA’s new post-marketing safety restrictions may mean higher costs for manufacturers and significant approval delays when you join FDC Reports and Sidley Austin LLP for this exclusive web conference!

The rules of drug and device regulation change every time the Food and Drug Administration applies the new safety tools handed to the agency by the FDA Amendments Act of 2007.

What does this mean for drugs and biological products?

"We are writing the history of drug regulation with what we are doing every day in response to FDAAA," said the FDA's top drug review manager, Office of New Drugs director John Jenkins at the June 2008 meeting of the Drug Information Association. "This is landmark legislation," he said. "It is on the order of the 1938 Food, Drug and Cosmetic Act, and the 1962 Amendments" that established the efficacy standard. "We're really in a new era."

Here's the thing: FDA is changing the rules of drug regulation on the fly, one application at a time – a point that Jenkins himself acknowledges. "Every application has to be handled as a unique application" when it comes to applying the new statutory authorities, he said.

Find out what are the likely implications for drug and biologic manufacturers. What drug and biologic categories are likely to be the hardest hit by the new restrictions? Where should you look for guidance? And how can sponsors respond most effectively to a REMS or other post-market safety restriction?

What does this mean for devices?

For years CDRH has been telegraphing its intentions to impose tighter post-market surveillance in certain product areas such as drug-eluting stents (DES). Since the passage of legislation last year commonly known as the Drug Safety Bill, the FDA has been making use of some new tools to protect patients from risk and not just for drugs and biologics. Devices are now being targeted for increased scrutiny, and regulators are beginning to see the applications of REMS for the device market.

Find out how device regulators are adopting REMS in the device approval process and what types of devices and diagnostics are most likely to encounter problems. Learn exactly what you need to know about these changes before it’s time to submit your next device or diagnostic for clearance or approval.

Join us forREMS: The New FDA Post-Market Safety Restrictions for Drugs & Devices on Thursday, Nov. 13, 2008 at 12:00 p.m. EDT (9:00 a.m. Pacific). Listen as our experts help you understand how the FDA is changing the drug and device approval process! Grab your team, a phone and a computer with Web access (that last one's optional). No travel required!

Walk away with guidance in the following areas:

  • What the new drug safety legislation means for drugs/biologics AND devices/diagnostics
  • What are REMS and how are the impacting they drug and device industries?
  • Which categories of drugs and devices are being hit the hardest?
  • What are the potential costs of post-market restrictions in terms of time and money?
  • How to prepare for drug and device approval process in light of potential significant product risks
  • Strategies  for working with FDA to help keep the approval process moving
  • How to ensure the best communication between your staff and FDA regulators
  • How to address REMS or other post-marketing restrictions for drugs and devices

…and much more!

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This webinar is aimed at executives in pharmaceutical, biotechnology and medical device companies, including:

  • Senior management
  • Corporate counsel
  • Regulatory affairs professionals
  • Compliance officers
  • Senior scientists
  • Consultants and lawyers

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Coleen Klasmeier
Partner
Sidley Austin LLP
Click here for more information

Coleen Klasmeier, a partner in Sidley's Washington, D.C., office, has practiced food and drug law for more than a dozen years. Her work encompasses the full range of regulatory issues confronting FDA-regulated companies.

Ms. Klasmeier is a past chairman of the Food and Drug Committee of the American Bar Association’s administrative law section, and a nationally recognized speaker on FDA regulatory issues.  She authors the FDA Advertising and Promotion Manual (Thompson Publishing), which is among the seminal references in that area of FDA regulatory practice.  Ms. Klasmeier is listed in Chambers USA and is “Recommended” in the United States regulatory area by The Practical Law Company in The Cross-Border Life Sciences 2007/08 Handbook.

Before joining the firm in January 2005, Ms. Klasmeier served as Staff Attorney/Special Assistant to the Chief Counsel of FDA.  In that position, she provided advice on the constitutional and statutory limitations on FDA authority and on policy matters to the Chief Counsel and to senior agency executives. She also focused heavily on the promotion of FDA-regulated products, the regulatory categorization of products, preemption of state product liability claims, and the relationship between FDA and the Securities and Exchange Commission.

Ms. Klasmeier is a 1996 graduate of The Boston University School of Law, where she was on the Law Review editorial board and received the Bigelow Award.


 

Lauren Silvis
Associate
Sidley Austin LLP
Click here for more information

Lauren R. Silvis is an associate in the Food and Drug Practice, focusing on FDA regulation of pharmaceuticals, biological products, and medical devices.

Ms. Silvis advises clients on drug and device safety issues, the regulation of clinical trials, recalls and FDA inspections, good manufacturing practice and the quality system regulation, the promotion of FDA-regulated products, import and export issues, and the regulation of over-the-counter drugs. She has worked on major transactions involving FDA-regulated firms and has conducted regulatory due diligence for both buyers and sellers of public and private companies. Ms. Silvis has also worked with clients in the food, dietary supplement, and cosmetic industries.

Recently, Ms. Silvis has:

  • Counseled drug and device manufacturers on compliance with clinical trial requirements, including clinical trial disclosure and results posting, patient registries, safety reporting, and negotiating clinical trial agreements;
  • Assisted clients in responding to inquiries and investigations into marketing practices; 
  • Provided regulatory advice to manufacturers of in vitro diagnostic devices regarding pathways to market for new products and the regulation of laboratory-developed tests.

Ms. Silvis served as a law clerk to the Honorable James L. Ryan on the United States Court of Appeals for the Sixth Circuit. She received her J.D., cum laude, from Georgetown University Law Center in 2002, where she was a notes editor for The Georgetown Law Journal. She received her A.B., cum laude, from Duke University in 1998.

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What are the unique benefits of a webinar?

  • Convenience – and lower cost. Your entire team can listen in one room. No travel required!
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  • Flexibility. Want to be able to review what you learn? No problem ... just register for the live webinar PLUS a digital copy of the entire event to listen to at your convenience. Interested in the topic but have a scheduling conflict? Don't worry — the recording is available for purchase at any time!

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REMS: The New FDA Post-Market Safety Restrictions for Drugs…
AND Devices!

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