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Dec. 23, 2013

Vol. 45
No. 50


Editor’s Note

Due to the holidays, Washington Drug Letter will not be published on Dec. 30, 2013. The next issue will be published Jan. 6, 2014. Read More

Breakthrough Therapy Pathway A Success for CDER in 2013

The FDA’s new breakthrough therapy designation has exploded in popularity, the agency says. As of Nov. 22, 108 requests for breakthrough designation have been submitted. Read More

Senate Vote on Budget Deal Offers Two-Year Protection for User Fees

The Senate last week voted 64-36 to approve a budget that will protect FDA user fees from sequestration cuts for the next two years. Read More

HHS Rejects PhRMA Plea to Annul 340B Orphan Drug Discount Rule

HHS stands by its final rule expanding 340B discounts to orphan drugs when certain hospitals and healthcare providers use them to treat non-rare diseases, the agency said in a court filing opposing PhRMA’s attempts to invalidate the rule. Read More

GSK Reforms Sales Practices in Wake of China Scandal

GlaxoSmithKline unveiled a new compensation system for its global sales force this week in a move hailed as a revolutionary change to improve ethical practices for drug sales professionals. But so far it’s a revolution of one. Read More

New Compounding Laws Don’t Change FDA Position on Makena

The FDA does not intend to prevent compounders from making preterm birth drug Makena (hydroxyprogesterone caproate), the agency stated in a legal filing earlier this month that outlines how it intends to approach one contentious issue involving compounders. Read More

Lawmakers Propose Bill to Ban Pay-for-Delay Deals

U.S. lawmakers Dec. 11 introduced legislation that would prohibit patent litigation settlements in which a brand drugmaker compensates a generic drugmaker to delay sales of a competing generic drug, commonly referred to as “pay-for-delay” deals. Read More

Public Citizen Raises Conflict of Interest Concerns for Advisors

A citizen watchdog group is again raising concerns about conflicts of interest on FDA advisory committees, charging that the agency should not have allowed a panel member to vote on a drug that a family member was taking. Read More

Four-in-Five Breakthrough Requests Denied By CBER

While FDA’s CDER breakthrough therapy designations for new drug products have taken off dramatically, CBER has been a lot more conservative in approving applications for the new designation. Read More

EU Lawmakers Advance Revised Trial Rules; Adoption Expected in Early 2014

An overhaul of clinical trial regulations in the EU took a big step forward Dec. 20 as officials paved the way for revised rules to replace the current clinical trial directive in early 2014. Read More

FDA Extends Comment Period for Generic Safety Labeling Rule

The FDA has extended by 60 days the comment period for its proposed safety labeling rule for generic drugs. Stakeholders now have until March 13 to comment on the proposal, which would allow generic drugmakers to update labels in response to safety issues without agency approval. Read More

Gilead Moves Closer to Dominating Hep C Market

Gilead Sciences’ drug Sovaldi appears primed to dominate the hepatitis C market with the release of new Phase III trial data showing subjects with genotype 1 of the virus benefit from the drug, without coupling it with interferon. Read More

FDA To Require Clinical Studies for OTC Antibacterial Soaps, Washes

The FDA plans to mandate that manufacturers of antibacterial soaps and body washes submit clinical outcome study data that address safety and efficacy of their products, regulating them as they would other OTC medications. Read More

FDA Continues to Defend Zohydro Approval, State Prosecutors Criticize

As more critics of the FDA’s approval of the painkiller Zohydro ER come forward, the agency says it will not limit approval of new opioid painkillers to those with abuse-deterrent properties. Read More

FDA, EMA Extend Joint Inspection Initiative to Generic Applications

The FDA and EMA will expand their joint inspection activities to include facilities involved with bioequivalence studies for generic drug applications. Read More

PhRMA Wary of FDA’s Call for Antibacterial Superiority Trials

PhRMA is pushing back against the centerpiece of the FDA’s draft guidance on antibacterial drug development, saying superiority trials for antibacterials that treat drug-resistant infections are “neither routinely possible nor consistently ethical.” Read More