In this week’s news, FDA urged to rejig testing rules for feeding tube meds, US FDA give states more time to revise compounded drug shipping rules and more…
Industry wants US FDA to revise oral drug feeding tube suitability tests
Drugmakers say the US Food and Drug Administration (FDA) needs to revise its recently issued draft guidance on testing the suitability of oral drugs for administration through enteral feeding tubes.
The draft guidelines – which were published in June – state drug firms need to undertake “consistent in vitro testing of oral drug products to demonstrate their suitability to be administered via enteral tube.”
The calls for revision were posted as comments in response to the draft guidelines last week.
The Association for Accessible Medicines, which represents generic drug firms called for more information on comparative testing. Meanwhile drug firm and CDMO Boehringer Ingelheim asked why the guidance does not cover oral solutions and asked if the agency is considering separate regulations.
Compounding issues: US FDA grants states more time to change regs
In other news the FDA has given US states another year to sign a memorandum of understanding (MOU) to control the distribution of compounded drugs.
The agency announced the decision on Monday, explaining the extension “will allow sufficient time for states to consider the final standard MOU and modify their laws and regulations.”
The 2012 Drug Quality and Security Act (DQSA) required that states sign a MOU to prevent an “inordinate” number of compounded drugs from being shipped to other states. States that sign must report adverse events. Those that do not sign was a distribution limit of 5%.
Also in the news
The WHO has called on world leaders and the pharmaceutical industry to end practices that are hindering some countries’ ability to source COVID-19 vaccines. See CNN report.
Developers and CDMOs are expected to earn billions in revenue from COVID-19 vaccines according to a report by the AFP.
All Africa reported that the Egyptian Government plans to encourage the country’s pharmaceutical manufacturing sector. The aim is to reduce reliance on foreign-made medicines.
Denmark has agreed to buy Novavax COVID-19 vaccines as part of EU deal according to Reuters.
Some developments of note in the contracting sector:
Moderna warned that supplies of its COVID-19 vaccines outside the US may slow down as a result of problems encountered by two CDMOs. See full Reuters report.
Inhaled medicines CDMO Vectura is the subject of a takeover battle between the Carlyle Group and cigarette maker Philip Morris International. Read more at Fierce Pharma.
See also related story about Philip Morris’ other moves in the healthcare space.
Recro Pharma has signed a non-binding letter of intent for the acquisition of an unnamed full service CDMO. See delightfully vague news release.
Money control looked at CDMO Windlas Biotech’s recent initial public offering on the Bombay Stock Exchange.
Almac has established a manufacturing agreement with Swedish biotech company, PILA PHARMA for the production of the API for the candidate diabetes treatment XEN-D0501. See full Contract Pharma story.