Blog Tag: Regulations

FDA Will Hold Hearing on Communications Regarding Unapproved Uses

The Food and Drug Administration has issued a notice announcing a public hearing on November 9 & 10, 2016 to gather input relating to companies’ communications about their medical products, with a particular focus on communications regarding off-label uses of approved drugs and medical devices.

Currently, the FDA regulates how pharmaceutical and medical device companies can communicate uses of their products through approved labels, but many of those companies believe that greater sharing of information could significantly enhance patient treatments and outcomes.  The press release explains that the FDA is aware of technological and business changes that are increasingly affecting medical decision making and prescribing.  Such awareness prompted the FDA to review its regulations and policies governing companies’ communications regarding unapproved uses of approved medical products.  The Agency anticipates that feedback from the meeting will help inform policy development in this area.

In the press release, specific attention is drawn to the FDA’s heightened interested in comprehensively understanding: how increased communications from companies regarding unapproved uses could impact the public health; how changes in the health care system that give payers and formulary committees more power in prescribing practices incentivize firms to provide more safety and effectiveness data; the impact of increased accessibility of information relating to medical products on companies’ incentives to communicate information about off-label uses; the standards that should apply to off-label communications to minimize the potential of harm; and what factors should be considered when evaluating whether communications regarding unapproved uses are misleading, including what information must be disclosed to ensure consumers are not misled.

In August, 2016, the Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Innovation Organization (BIO) released guidelines intended to improve communication between biopharmaceutical companies and other health care professionals.  Following the FDA’s announcement of the November meeting, Jeff Francer, Vice President and Senior Counsel of PhRMA, issued a statement praising the FDA on its efforts to modernize its regulations surrounding information sharing:

Given our increasingly data-driven, value-based health care system, we hope that FDA will act quickly to define new and clearer regulatory standards to permit responsible sharing of information and data about medicines with other parties in the health care system.

Comments will be accepted after the hearing, until January 9, 2017.

EU Reaches Deal on New Medical Device Regulations

The European Parliament and European Council recently jointly announced an agreement regarding new rules on medical devices and in vitro diagnostic medical devices.  The process that lead to the agreement began in 2012.  According to the press release, the goal of these new regulations is to:

mak[e] sure that medical devices and in vitro diagnostic medical devices are safe while allowing patients to benefit [from] innovative health care solutions in a timely manner.

The press release notes that the draft regulations will accomplish these goals by strengthening the rules on placing devices on the market and tightening surveillance once they are available.  Regarding the agreement, Edith Schippers, Minister of Health of the Netherlands and President of the EU Council stated:

The deal reached will improve patients’ health and it will help to enhance the quality of life of disabled persons. It will also ensure a level playing field for the 25 000 medical devices manufacturers in the EU, many of which are SMEs and which employ more than half a million persons.

Organizations such as the European Society for Cardiology and MedTech Europe have hailed the agreement as a significant step forward.  Serge Bernasconi, CEO of MedTech Europe said:

The medical industry recognises the importance of these updated regulations. The implementation will require substantial resources from all stakeholders, including industry. It is thus essential to keep the overarching goals of patient safety and innovation in mind during the translation into implementable rules.

If the Parliament’s ENVI Committee (i.e., the Committee on Environment, Public Health and Food Safety) and the EU Council confirm the agreement later this year, the new rules will apply three years after publication for medical devices and five years after publication for in vitro diagnostic medical devices.  A draft of the new regulations is not yet available, but the press release provides the following notable details on the expected content.

Expected Impact of Draft Regulations on Device Manufacturing

  • “[F]urther tighten the rules for the independent bodies that are responsible for assessing medical devices before they can be placed on the market”
  • “[S]trengthen the surveillance of these so-called notified bodies by national authorities”
  • Give the notified bodies “the right and duty to carry out unannounced factory inspections”
  • Manufacturers will be responsible for “the follow-up of the quality, performance and safety of devices placed on the market”
  • “Manufacturers and other economic operators will have clear responsibilities, for instance on liability, but also on registering complaints on devices”
  • Improved availability “of clinical data on devices”
  • Strengthen the protection for “patients participating in clinical investigations”
  • Increased checks by experts for certain high risk devices

Expected Impact of Draft Regulations on Transparency and Traceability 

  • Creation of a central database for “all relevant information”
    • “It will cover economic operators, notified bodies, market surveillance, vigilance, clinical investigations and certificates”
    • “It will provide patients, healthcare professionals and the public with comprehensive information on products available in the EU”
  • “Patients who are implanted with a device will be given key information on the product, including any precautions which might need to be taken”