The Rise of the Medical Device/Pharmaceutical Product combination and how it affects traditional Pharmacovigilance

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1 German Pharmacovigilance Day 02. June 2015 The Rise of the Medical Device/Pharmaceutical Product combination and how it affects traditional Pharmacovigilance

2 Abstract Abstract Medical Devices and Pharmaceutical products have long been separate worlds with distinct regulations. Advances in technology continue to create new opportunities by merging devices with drugs or biologics to provide previously impossible benefits to patients. As these combination products involve components that are normally regulated under different types of regulatory authorities, they raise several challenges to traditional pharmaceutical companies, not previously exposed to Device regulations. Compared to drug regulations, device regulations are more diverse depending on the classification of the device. But the safety of Medical Devices has recently become the focus of regulatory activities in Europe following the scandal about industrial silicone breast implants in France, leading to changes in regulations that follow Pharmacovigilance principles. In this presentation Dr Marc Zittartz, Chief Quality Officer at pharmasol, provides an overview on drug-device combinations, the recent regulatory developments, and how this affects the traditional Pharmacovigilance activities of pharmaceutical companies.

3 In the past Medical Devices and Pharmaceutical products were well separated Different companies Different regulations

4 Device Classification Class I: lowest potential for harm and are simpler in design

5 Device Classification Class II

6 Device Classification Class III

7 THERAC-25 Linear accelerator to deliver x-rays and electron beams for the treatment of cancer Released in 1985

8 What went wrong? Within 2 years, 6 patients received massive radiation overdose due to a software failure

9 Recent Device Safety issues DePuy Hip Replacements - Approved without Clinical Trials in % of patients who received the device needed revision surgery. Poly Implant Prothèse - Breast implants from industrial-grade silicone - 500% higher risk of rupturing or leaking - implicated in at several deaths due to systemic toxicity and several cases of induced breast cancer

10 Combination Product Definition (FDA) (1) A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are combined or mixed and produced as a single entity; (2) Two or more separate products packaged together and comprised of drug and device products, ; (3) A drug, device, or biological product packaged separately that is intended for use only with an (approved) individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect From <

11 What is the problem? Technological advances continue to merge product types Combination products contain components that individually would be regulated by different types of Authorities Biologics FDA CBER Pharmaceuticals CDER Devices CDRH

12 The FDA solution: OCP Office of Combination Products (OCP) Established in 2002 Ensure Identify PMOA (Primary Mode of Action) prompt assignment of to FDA Centers, timely and effective premarket review, consistent and appropriate postmarket regulation.

13 Advantages Of Developing Combination Products Approximately one-third of all medical products under development today are combination products. According to data published by Research and Markets, the drugdevice combination products segment alone will grow to $115 billion by From <

14 Endeavor Drug-Eluting Stent Scaffold coated with a drug to prevent scar tissue from growing in an artery

15 Exubara Inhaled Insulin Combination Product for Treatment of Diabetes

16 Ionsys Fentanyl HCl Patient-Controlled Iontophoretic Transdermal System

17 Combination Product Safety How is the product approved (Drug, Device, Biologic)? Which regulations apply? Which regulations should apply? Postmarket Safety Reporting for Combination Products - Concepts for Comment (PDF - 41KB)

18 How to manage different reporting obligations? Device Malfunction Reporting - Reporting of device malfunctions where no death or serious injury occurred, but it would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.

19 How to manage different reporting obligations? 5-Day MDR Reporting - (1) any reportable event that necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health, and - (2) any MDR reportable event for which FDA has made a written request for the submission of a 5-day report.

20 How to manage different reporting obligations? Drug and Biological Product Alert Reporting - adverse events that are both serious and unexpected. - Device safety reporting requires 30- day reports of any serious injury, the reports would not necessarily flag an event as both serious and unexpected

21 Additional Information to be captured Model #, Serial #, Lot # Expiration Date Who operated the device Evaluation of Device Interaction with Manufacturing department

22 In a nutshell Combination Products are on the rise Provide benefits to patients Medical Device regulations are getting tighter Gaps in regulations between Drugs and Devices become apparent