Boomerang: EMA Goes from Hunter to Hunted

Boomerang: EMA Goes from Hunter to Hunted

Regulatory agencies spend more time investigating others than being investigated by others, but the European Medicines Agency is now on the hot seat over what is purported to be a lack of transparency regarding premarket interactions between it and drug makers. This is quite a reversal of the typical dynamic, such as when the EMA orders drug makers to withdraw their products from the EU market, but companies in the life sciences might not think the agency’s new transparency problem is a good problem for industry.

EU Ombudsman Investigating Presubmission Meetings

Allegations that regulators are all to cozy with industry are typically leveled at the American FDA, but that problem seems to have migrated to the other side of the Atlantic Ocean. Former journalist Emily O’Reilly, who took the job of European Ombudsman in 2013, has advised the European Medicines Agency she intends to open a “strategic inquiry” into pre-submission activities between the European Medicines Agency and regulated entities.

O’Reilly is no stranger to controversy, having penned three books that struck a number of nerves, but she also took the government of Ireland to task for what she saw as a problem with transparency. The theme of transparency appears in her July 17 letter to EMA executive director Guido Rasi, which states that pre-submission interactions with EMA staff and industry “may pose some risks,” such as that reviewers at EMA may be influenced by applicants in these interactions. O’Reilly acknowledges that these pre-submission meetings are not necessarily problematic, but said there is risk that these meetings create “in the eyes of the public, at least some perception of bias,” a hazard she asserts “must be managed.”

This risk could be managed by more transparency, O’Reilly continues, stating also that “a preliminary assessment suggests that more could be done in this area” without offering any details related to that preliminary assessment.

O’Reilly inquired as to whether EMA publishes “detailed minutes of pre-submission meetings,” which may strike some in industry as incurring the hazard of loosing the lid on proprietary information. She asked EMA to provide details of such meetings dating back to 2012, and asked for a list of the 10 companies that “met most frequently” with EMA staff in pre-submission meetings.

The inquiry is certain to raise a few hackles, but it’s anyone’s guess as to how far this will go and whether EMA will find this sufficiently distractive to impede the agency’s handling of priority review applications, which are also referenced in O’Reilly’s letter. At the very least, this is a matter that bears watching.

EMA Hits Gadoliniums After FDA Stands Pat

The EMA is no stranger to imposing its will on others, as demonstrated by the fact that it has followed through on a threat to suspend the marketing authorization for three gadolinium-based MRI imaging agents, a move that was not paralleled in a similar FDA review. Among the products up for suspension is one route of administration for Magnevist, a linear gabapentin-based contrast agent (GBCA) manufactured by Bayer Schering Pharma, but the macrocyclic GBCAs escaped relatively unscathed in this review.

The FDA began its investigation into the effects of deposits of GBCAs in human tissues in 2015, but announced in May that it had no data on hand to suggest that retention of these agents in the brain is harmful for most patients. The agency affirmed the notion that linear GBCAs are more the more likely of the two types to be retained in the human body, and said the only known problem is nephrogenic systemic fibrosis, said to occur only in “a small subgroup of patients” who had been diagnosed with kidney failure. The FDA said it would continue to track these patients.

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) said earlier in July that it had confirmed “that there is convincing evidence of gadolinium deposition in brain tissues” with the use of gadolinium contrast agents, but while PRAC did not identify specific conditions in connection with deposits in the brain, the committee recommended that EMA suspend the use of Magnevist (gadopentic acid) and two other linear GBCAs, Omniscan (gadodiamide) and Optimark (gadoversetamide).

EMA’s July 21 announcement confirmed the suspension of marketing authorizations for the three linear agents cited by the PRAC, while stating that another linear GBCA, Multihance (gadobenic acid) should be restricted to use in scans of the liver. Another linear GBCA, Primovist (gadoxeticacid), was untouched by the EMA action, although it should be noted that the agency will allow Magnevist to stay on the market for intra-articular use despite the suspension of its use via intravenous administration.

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