In this week’s news, FDA and industry talk rare diseases, EFPIA wants access to meds forum and more…
Rare diseases, NME and post market rules mulled in PDUFA VII talks
The US FDA and industry discussed language related to new molecular entities and post-marketing requirements during the most recent round of PDUFA VII talks.
According to minutes released this week negotiators in January covered both subjects in detail with the FDA agreeing to formalize timelines.
“FDA clarified that the pre-approval communication timelines discussed for standard and priority NME NDAs and original BLAs, if implemented, would be formal commitments under PDUFA VII rather than suggested best practices.
In addition “Both sides discussed aspects of the process for reviewing existing PMRs post-approval, including the feasibility of proposed timelines for providing decisions to Sponsors following a request for PMR release and information to be included in the decisional letter from FDA.”
The parties also talked about plans for a pilot program that would provide additional interaction between FDA and sponsors to facilitate the development of rare disease novel endpoints.
EFPIA calls for EC forum to address access to medicines
Industry group EFPIA says the European Commission should set up a forum to discuss how to improve access to medicines.
The proposal – which comes amid European Union plans to implement joint health technology assessments (HTA) – is designed to address issues – which EFPIA says – limit access to medicine in the EU.
EFPIA wrote that, “[the issues] range from a slow regulatory process, late initiation of market access applications, reimbursement delays due to inefficient processes and duplicative evidence requirements, and finally, a slow uptake of innovation due to local formulary decisions and endorsement by clinicians.
EMA to revamp adverse event reporting system
The European Medicines Agency (EMA) has announced plans revamp its system for reporting adverse events related to drugs.
The Amsterdam-based regulatory said it will change its EudraVigilance adverse event system to allow users to report individual cases of suspected side effects using the ISO ICSR/ICH E2B(R3) format.
Italian regulators concerned about counterfeit surge
AIFA says it is concerned about an increase in reports of counterfeit drugs
The regulator made the comments in a notice this week (here in Italian) explaining that many of the reports related to medicines purchased online.
It wrote, “AIFA has recently recorded a worrying increase in reports received from citizens, associations and companies of products purchased online from unauthorized channels, falsified or illegal results and draws attention to the risks associated with this type of purchase.”
AIFA cited fake versions of Somatoline cream , a dermatological preparation with anti-cellulite activity, and Cialis, a medicine indicated in the treatment of erectile dysfunctions, as examples.
It advised “consumers to be wary of what on the web, often and frequently, are presented as “unmissable offers”, recommending the utmost caution in purchasing drugs online.”
Also in the news
STAT reported that the US Congress is investigating US CDMO Emergent BioSolutions’ federal vaccine contracts after multiple issues detected at the plant where it makes J&J Covid-19 shot.
RAPS examined the problems identified at Emergent’s facility in Baltimore.
Fortune took a look at the drug companies and CDMOs that make COVID-19 vaccines.