Regulatory Focus™ > News Articles > Five in Focus – India Pushes for More Compulsory Licenses, EMA's Fight for Transparency and Reform

Five in Focus – India Pushes for More Compulsory Licenses, EMA's Fight for Transparency and Reform

Posted 03 May 2013 | By

Hello and welcome to a new  edition of Five in Focus, our Friday recap of the five most important, interesting, riveting or ground-breaking stories of the week.

If You Give a Mouse a Cookie… The Case of India and Compulsory Licenses

A landmark judicial ruling isn't precedent until it has a following. And this week, India's Union Health Ministry showed that a court case decided late in 2012 is indeed the dangerous precedent that many in industry contended it might be.

The crux of the issue is thus: Government officials, seeing that the country's citizens can't access certain cancer medications because of their high costs (which can be three times a patient's yearly income), have moved to promote generic competition through the use of compulsory licenses. Those licenses effectively negate a company's patent on a case-by-case basis. Industry, meanwhile, says this damages innovation, and ignores the research and investment that went into making the investment.

Now India is out with three more proposals for compulsory licenses, and both sides can expect to hear a lot of the same arguments that came out in the Nexavar debate in 2012. The only question: Who will prevail? [Read more…]

Transparency, Biosimilars and Agency Changes: EMA's Big Week

The European Medicines Agency (EMA) has been uncharacteristically quiet this year. That may be a good thing considering the number of scandals it's seen in recent years, but this week saw a flurry of major activity coming out of the agency.

The biggest may well be the news that it plans to totally overhaul how it regulates medical products, including new human medicines, part of a series of institutional changes being made at the agency. The main changes will see EMA's current two medicines units reorganized into four: One to support R&D, another for evaluation and lifecycle management, a third for procedure management and business data and a fourth for inspections and pharmacovigilance. [Read More…]

But the two other news items of the week were potentially just as big for many in industry. EMA announced a clarified framework for biosimilar medicines, saying that data for comparability studies could come from outside the European Economic Area (EEA), so long as the sponsor could show the outside-the-EEA medicine was the same as the one marketed in the EU. That could potentially allow sponsors of biosimilar products to get more mileage out of their studies, and particularly ones conducted outside the EEA). [Read More…]

EMA also sounded the alarm about a new court decision that ordered it to halt its clinical trials transparency initiative after AbbVie and InterMune sued the agency in court, citing potential damages to their trade information if the information was released as intended. A judge agreed with that argument enough to place the transparency initiative on hold while the case winds its way through the legal system. EMA, for its part, said it remains "committed to transparency and openness of information." [Read More…]

Birth Control Politics Are Back, and so is Plan B

Is there anything quite as contentious in American politics as birth control? As this week seemed to remind us: No there is not.

On Tuesday, FDA announced that it had approved Teva Women's Health's application to allow Plan B One-Step, a birth control product based on the already-approved levonorgestrel, to be sold over-the-counter (OTC) to women as young as 15 so long as they had proper identification. What government-issued ID does a 15 year-old have? We're not sure either. [Read More…]

But even as the decision infuriated some on the right, the Obama administration infuriated many of its left-wing supporters by appealing a decision passed down last month that would have seen the same drug made available to girls as young as 10 without a prescription. While FDA and the Department of Justice argued that the decision was based on improper authority, that did little to placate its critics, who saw the administration as either attacking women or not doing enough to protect children. [Read More…]

A Week of Major Staff Changes at FDA: Autor, Brenner-Gati Out; Howard In

Whether the officials were coming or going, no week in recent memory has seen quite so many officials changing over at FDA. The week was already off to a fast start when FDA announced the hiring of Secretary Kathleen Sebelius' former chief of staff, Sally Howard. Howard will now serve as the deputy commissioner for policy. The hiring comes after a contentious period between FDA and Sebelius, who is the first DHHS secretary ever to overrule an FDA approval decision. [Read More…]

But just hours after news of Howard's hiring broke, an even bigger piece of news came out: Deborah Autor, the deputy commissioner for the Office of Global Regulatory Operations and Policy (GO), is leaving the agency on 1 June 2013 to join Mylan Pharmaceuticals. Autor, an 11-year veteran of FDA, is in charge of FDA's field inspection team, and leads a staff of around 4,400. [Read More…]

And on Friday, another official, Leona Brenner-Gati, acting deputy commissioner of medical products and tobacco, said she was leaving the agency effective immediately, citing unspecified personal reasons. A fourth official, Mary Beth Clarke, joined the agency on Monday as director of the Office of Executive Programs. [Read More…]

French Regulator Back in the Spotlight-Again, and for Unenviable Reasons

If a spotlight was a medical device, you can only imagine that regulators would like to dispute its safety, if only to keep its light off its back for a while.

That's because for at least the third time in recent years, French regulators are facing major embarrassment for failing to keep an un-cleared medical product away from consumers. This time medical device manufacturer Ceraver is accused of marketing a hip implant device without proper CE marking, potentially putting consumers at risk. [Read More…]


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