Feature Articles

FDA’s Banner Year for Drug Approvals: Time to Change the Focus / FDA is entering a big legislative year with a good story to tell based on 30 new molecular entity approvals. But the level of submissions remains constant—suggesting it may be time to shift the focus from what comes out of FDA to what makes it in. / The RPM Report January 2012

An Emerging Approval Trend At FDA: More First-Time Sponsors / There is a surprising trend in the list of FDA approvals in 2011: an increase in the number of small biopharma companies opting to forgo Big Pharma partnerships and submit new product applications on their own. Here’s how these “emerging sponsors” are changing the way FDA does business—for big and small companies alike. / The RPM Report January 2012

FDA “Flexibility” Presages Good Climate in 2012 for Approval Decisions, Shortage Situations / As FDA girds for the Capitol Hill phase of the user fee reauthorization push in 2012, the agency is projecting an image as a flexible problem-solver. FDA’s underlying message: the agency has sufficient authority and does not need tinkering with the legislative mandate. / The RPM Report January 2012

FDA Beat

Plan C? The Plan B Decision and Calls for a Third Class of Drugs / HHS Secretary Sebelius’ decision to overturn FDA’s approval of Plan B for widespread over-the-counter use was disappointing to many drug reviewers inside the agency. But FDA’s Office of New Drugs Director John Jenkins says the move should be used to reopen the debate over whether to create a third class of drugs. / The RPM Report December 2011

CMS Beat

Big Pharma’s Government Bailout / The only thing driving 2010’s prescription drugs spending? Medicare. / The RPM Report December 2011

Specialty Tiers Ensure Part D Plans Cover High-Cost Biologics, Blum Says / CMS Medicare director Jonathan Blum acknowledges there is a “robust debate” within CMS regarding specialty tiers in Part D but says he believes permitting plans to charge beneficiaries higher cost-sharing for expensive biologics preserves access to such drugs. / The RPM Report January 2012

The Real Obesity Drugs Hurdle: Paying for Them / Obesity drugs are readying for round two at FDA. But if ever approved, given the airing of safety issues at advisory committee meetings, who would pay for them? / The RPM Report January 2012

Street Smarts

All the Guidance They Need: Biosimilars Business Development Doesn't Wait For FDA / Wall Street is eagerly awaiting formal guidance from FDA on the new biosimilar pathway in the US. Biotech companies large and small aren't waiting. / The RPM Report January 2012

Pointed View

What Might Have Been? The Gingrich FDA Reform Platform / Former House Speaker Newt Gingrich hasn’t forgotten his interest in FDA reform: one theme of his Presidential campaign has been to revisit some of the arguments that underpinned the GOP reform legislation of the mid-1990s. At press time, the chances of Gingrich winning the nomination appeared remote—but for a brief time late in the fall it looked like FDA might take center stage in the upcoming elections. / The RPM Report January 2012