The US Food and Drug Administration (FDA) is not just seeing an increase in drug shortages but also a spike in the intensity and duration of shortages, according to agency presentations at an FDA/Duke Margolis Center for Health Policy event on Tuesday. Matthew Rosenberg, an economics staffer at FDA, looked at drug shortages in terms of occurrence, duration, intensity and public health impact. Combining data from FDA archives and IQVIA national sales database, Rosenbe...

Beginning 1 January 2019, drugmakers will be required to report drug shortages in Australia, the country's Therapeutic Goods Administration (TGA) announced Tuesday. “Medicine shortages have become an increasing problem in Australia, as the current voluntary scheme for reporting shortages has proven ineffective,” TGA said, noting that many critical shortages are not currently reported, meaning such information cannot be shared with consumers and health professionals, whi...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Seeks Feedback on Drug Data Management Practices China is seeking feedback on its draft drug data management practices. The China Food and Drug Administration (CFDA) text details how individuals and organizations involved in the development, production, distribution and monitoring of drugs should ensure the accuracy and traceability of the data they generate. C...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. MHRA Chief Floats Faster Reviews, Closer Ties to NICE as Post-Brexit Options for UK The head of the United Kingdom’s regulatory agency has sketched out some of the ways it may change after Brexit. Dr Ian Hudson stressed the UK wants a collaborative, ongoing relationship with the European Medicines Agency (EMA) but is preparing for the opportunities — and risks — that w...

India's patent office has granted Pfizer a patent on its pneumococcal conjugate vaccine (PCV), known as Prevnar 13, after Doctors Without Borders (MSF) challenged the patent’s claims. The decision follows a campaign from MSF that began in March 2016 to allow for more affordable versions of the vaccine to come to market in India. In October 2016, MSF rejected a Pfizer offer to donate a significant number of PCV doses. "By giving the pneumonia vaccine away for fre...

Doctors Without Borders (MSF) on Friday appealed the US Department of Defense’s decision to grant an exclusive, royalty-bearing license to Sanofi Pasteur for patents to a Zika vaccine developed with US government funds. "MSF objects to the granting of an exclusive patent license on a U.S. government-funded invention to a single pharmaceutical company as well as to the lack of conditions to ensure the vaccine will be appropriately developed and made available and ...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EU GMP Inspectors Issued Non-Compliance Statements to 11% of Indian Sites Visited in 2016 Authorities in the European Economic Area (EEA) issued non-compliance statements to 11% of the Indian drug manufacturing plants they inspected in 2016. The rate of non-compliance is far higher than the 1% recorded globally in 2016 and the 4-6% level seen in India in the three prev...

As part of efforts to protect the US against chemical, biological, radiological, and nuclear (CBRN) threats, the US Food and Drug Administration (FDA) approved seven new treatments and 21 new devices in FY 2016, according to a program update on medical countermeasure (MCM) activities. With a budget of a little more than $110 million, FDA’s MCM efforts play a  critical role  in protecting the US from dangerous threats and emerging infectious disease threats, such as pand...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Asks China to Expedite GMP Inspections, Resolving Essential Medicine Shortage India has resolved the shortage of a rare disease drug after asking China to expedite the inspection of a manufacturer of active pharmaceutical ingredients (APIs). The Drug Controller General of India (DCGI) made the cross-border intervention to accelerate the resumption of API supply ...

On Monday, President Donald Trump signed an executive order to freeze all federal government hiring and with the US Food and Drug Administration (FDA) lacking almost 1,000 employees, the freeze could further slow new drug, medical device and generic drug approvals. What’s unclear right now is whether the order, which stipulates that the “head of any executive department or agency may exempt from the hiring freeze any positions that it deems necessary to meet national s...

Doctors Without Borders (MSF) on Monday objected to the US government’s granting of an exclusive patent license to Sanofi Pasteur for a developing Zika vaccine, though Sanofi fired back on Tuesday explaining the risks of developing such a vaccine. According to a Federal Register notice from 9 December, the Department of the Army of the US Department of Defense intends to grant an exclusive, royalty-bearing, revocable license on a patent entitled, ‘‘Zika Virus Vaccine an...

Sanofi Pasteur said it’s discontinuing the manufacture of TheraCys, an important bladder cancer drug, and shortages are expected, while the US Food and Drug Administration (FDA) on Friday released draft guidance to help develop new treatments for BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC). Benjamin Davies, MD, an associate professor of urology at the University of Pittsburgh School Of Medicine, writing in Forbes on Thursday, called on the government t...