Pharmaceutical And Medical Device Applications Committee

The Pharmaceutical and Medical Device Applications Committee (PMDAC) is an essential way for companies in the medical supply chain to engage with PLASTICS.

PMDAC is comprised of members from throughout the plastics supply chain involved in the manufacture of plastic pharmaceutical and medical devices. It includes business owners, senior-level executives and quality and regulatory specialists representing raw material suppliers, formulators and compounders, auxiliary equipment manufacturers, mold makers, processors and brand owners.

Plastics occupy a dramatically important place in modern medicine, and have largely displaced traditional devices made of metal, ceramics and other materials. 

Increased reliance on plastic pharmaceutical and medical devices has generated remarkable breakthroughs that enhance the delivery of medical care and make it easier for billions of people to live healthier, longer lives.

For example:

• Today’s prostheses are vastly superior to previous designs thanks to the use of advanced plastics that have more tensile strength, are more resistant to liquids and are lighter than other materials.
• Advanced plastic prostheses can even anticipate the body’s movements and adjust themselves accordingly.
• Newly-developed dissolvable plastic pill capsules are capable of releasing exactly the right dosage of active ingredients at specific times, reducing the risk of accidental overdose and the need for patients to frequently ingest large quantities of pills.
• People with severe hearing loss can now have a plastic implant that stimulates the auditory nerve directly and brings sound back to their ears.
• Artificial corneas made from plastics can restore clear vision to patients suffering from eye injuries.
• Stents made from corn-based plastic are being used to improve blood flow in clogged or blocked arteries. The body absorbs these stents after two years, reducing the risks associated with permanent metallic stents.

PMDAC is a public policy committee within the Plastics Industry Association (PLASTICS) Processors Council comprised of companies that make many of these innovations possible. The committee brings company representatives together to:

• Educate members through ad hoc meetings and webinars hosted regularly.
• Improve communications among manufacturers along the supply chain about plastics used in pharmaceutical and medical device applications.
• Write and promote voluntary standards or guidance documents for the supply chain to help maintain a level playing field for domestic and global medical manufacturers.
• Accelerate “speed to market” for novel medical applications.
• Address the impact of sustainability/recycling initiatives for manufacturers within the medical sphere.
• Monitor timely regulatory developments related to plastics used in medical applications.

RECENT PMDAC PROJECTS AND HIGHLIGHTS:

USP Working Group: The U.S. Pharmacopeial Convention (USP) creates new standards and revisions to existing standards for medical packaging systems and their materials of construction. In an effort to be exceedingly prepared and ahead of the curve, PMDAC has been working closely with USP and created a small working group of PLASTICS plastic packaging-related members, with technical expertise on drug packaging materials and systems, to engage directly with USP’s Packaging and Distribution Expert Committee. This will ensure that pharmaceutical experts are consulting with drug packaging experts on forthcoming new standards or revisions.

Drug Master File Guidance: Prepared for suppliers of packaging material for medical projects, this document serves as a guide to the regulatory considerations and procedures to be taken into account when establishing Type III Drug Master Files.

Executive Summary on Marketing Claims Related to Phthalates: Provides practical guidance on the appropriate way to communicate with the supply chain about the presence of phthalates.

Global Trade and Medical Devices: Created by PLASTICS, this presentation lays out the drivers for global trade, current exports and growth opportunities for medical devices.

Change and Certification of Materials in Medical Devices: Launched by PLASTICS, this advanced working group has completed the documentation of requirements to qualify a material for use in a medical device for all parties in the supply chain. Currently, PMDAC is finalizing a best practices resource guide for communicating and documenting changes to materials used in medical devices.

Drug Master File Working Group: PLASTICS and our members engaged in the pharmaceutical and medical device industry are very concerned about the new electronic filing format (eCTD) submission requirement for Type III Drug Master Files (DMFs). For your information, Type III DMFs are related to packaging. The electronic submission requirement is extremely burdensome and very costly and will push many companies out of the market entirely.   

The DMF Working Group was successful in receiving a compliance extension from FDA until May 2019. In January 2019, certain members of the DMF Working Group met with FDA to reiterate the cost and complexity of implementing eCTD submissions for Type III DMFs which compromises the business argument to continue manufacturing drug packaging components. FDA staff were receptive to these concerns and were very appreciative that companies were present to re-emphasize their concerns and share specific examples. FDA noted that the agency is aware of the issues and is examining possible solutions. In response, the FDA postponed the deadline for compliance until May 2020.

In July 2019, the FDA released proposed guidance to permanently exempt Type III DMFs from the eCTD requirements. This proposal to permanently exempt Type III DMFs from these eCTD requirements represents a significant victory for PLASTICS and members engaged in the pharmaceutical and medical device packaging industry.