In this week’s news, industry proposes track and trace oversight group, FDA plans further efforts with compounded drugs, TGA to revamp device review and more…
PDSA proposes oversight body for DSCSA mandated data exchange
US industry group says an oversight body would help contract drug firms, distributors and wholesalers follow US track and trace laws.
The Pharmaceutical Distribution Security Alliance (PDSA) made the suggestion last week, citing tracking rules that come into effect in 2023.
The regulations – part of the 2013 Drug Supply Chain Security Act (DSCSA) – call for drugs to have an ID number. From 2023, all firms in the supply chain must have systems able to exchange, read and record these codes.
Such exchange requires careful management according to the PDSA, which wants to set up an independent group to govern the systems and data transfer.
Full details available here.
US FDA to continue to work with drug compounders and CMOs
The US FDA has said it will continue to help compounding pharmacies and CMOs find risks at manufacturing facilities.
The regulator confirmed it would spend some of its 2019 budget on developing policies relating to the safety and quality of compounded drugs last week.
Compounded drugs are modified to fit needs of a particular patient. For example, if a patient is allergic to lactose, a compounder can reformulate a pill containing the sugar with an alternative.
Compounded drugs are not subject to FDA review and, in previous decades, the agency paid them little attention. This changed in 2012 when meningitis linked to such products killed 64 people.
In one of his last statements as agency head Scott Gottlieb said, “We’ve taken significant new steps to modernize and clarify our policies related to the quality of compounding in an effort to ensure continued access to compounded drugs for patients who need them, while also protecting patients from the risks of contaminated or otherwise harmful products.
“We anticipate that 2019 will be an equally productive year for the FDA’s compounding program, with better quality continuing to be our top priority as part of our ongoing effort to reduce the risks of these unapproved products.”
Read the full statement here.
Australian TGA suggest medical device review revamp
Australian regulators say they want to change how it checks new medical devices are safe.
The Therapeutic Goods Administration (TGA) published plans to revamp device reviews last week. It suggested assessments should take potential risks posed by each device into consideration.
For example, for devices deemed to be “medium-risk,” the TGA said it may mandate manufacturing site inspections. Likewise, for “high-risk” devices like spinal inserts the agency may ask for more data to prove efficacy.
The TGA also wants to address growing concerns about medical device security. It wrote, “The TGA will establish a specialist unit to better evaluate emerging technology such as 3D printed devices and software apps, as poorly performing apps may pose a significant consumer risk.
“It will examine ways to better monitor device cybersecurity risks. The TGA will provide clearer guidance to industry on cybersecurity requirements for medical devices and the IT systems they connect with.
See the TGA’s action plan for medical devices here.
Also in the news
ISPE looked at trends in the generic drug industry with four experts from the sector.
New Government policies designed to encourage the manufacture and use of generic drugs could save China’s healthcare system billions according to a Bloomberg article.
Regulators on either side of the Atlantic are thinking about working together on accelerated reviews for pharmaceuticals according to Pharmaintelligence (subscription required).
US President Donald Trump is yet to provide details of the system he wants to replace Obamacare. The New York Times took some educated guesses at what Trump might do.
FiercePharma put together a list of the top 15 pharmaceutical companies based on revenue generated in 2018.