The Senate Health, Education Labor & Pensions Committee (HELP) on Tuesday advanced seven bills that could serve as piecemeal counterparts to House-passed Cures legislation from last year. The swath of new bills would, among other things, streamline the US Food and Drug Administration’s (FDA) review process for innovative medical devices, bolster FDA's oversight of reusable devices, accelerate the approval process for some “targeted” rare disease drugs and aid the Nationa...

Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), told senators Thursday that FDA is making significant progress in reducing the backlog of abbreviated new drug applications (ANDAs) for generics and the agency expects that it will be fully caught up by the next re-authorization of the Generic Drug User Fee Act (GDUFA) in 2017. Since 2012, when the first GDUFA was created to provide FDA with indu...

The US Senate Committee on Health, Education Labor & Pensions (HELP) on Tuesday voted in favor of letting the full Senate vote to approve Robert Califf as the next Food and Drug Administration (FDA) commissioner. HELP Committee Chairman Lamar Alexander (R-TN) called Califf “the right man to lead the FDA,” as others offered their support. Sen. Lisa Murkowski (R-AK), who said back in November she would put a hold on Califf’s nomination, said at the hearing that she “g...

The article analyzes the proportion of FDA Advisory Committees specifically asked to discuss or vote on issues related to post-approval safety activities. Introduction Preparing effectively for a US Food and Drug Administration (FDA) Advisory Committee meeting requires the sponsor team's anticipation of discussion and voting topics FDA will pose to the advisory panel. Discussion topics and voting questions will influence information the team provides to the panel as w...

Sens. Susan Collins (R-Maine) and Claire McCaskill (D-Mo.) hosted a hearing Wednesday to discuss steep price increases for some off-patent drugs and what can be done to ensure patients and hospitals can afford these drugs moving forward. The hearing, which is the first in a series that focuses on companies that, as Collins puts it, “act more like hedge funds than pharmaceutical companies,” follows letters sent to four specific companies – Valeant Pharmaceuticals, Turin...

This article discusses the nuances of FDA Advisory Committee approval meetings and provides an interpretive overview of what regulatory professionals need to know to prepare for a meeting. Introduction The US Food and Drug Administration (FDA) define an Advisory Committee simply as a group of external experts convened to offer advice to the agency. However, in realty, the practice is more complicated. In other places on its website, FDA states Advisory Committees can ...

A group of health advocacy organizations are calling on the Senate Committee on Health, Education, Labor and Pensions (HELP) to tighten requirements for obtaining priority review vouchers for drugs for tropical diseases. In a letter addressed to HELP Committee Chairman Lamar Alexander (R-TN) on Tuesday, seven organizations including Médecins Sans Frontières (MSF), Drugs for Neglected Diseases Initiative (DNDi), Center for Global Health Policy, TB Alliance, Treatment Acti...

The US Food and Drug Administration (FDA) is making it clear to Congress that it's up to the task of regulating lab developed tests (LDTs). Speaking at a House Energy & Commerce Committee hearing today, Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health (CDRH) defended the agency's plan saying, "Getting the right treatment to the right patient at the right time depends on having accurate, reliable and clinically validated tests." Unlike traditi...

Senators on both sides of the aisle offered their support for Robert Califf to be the next commissioner of the US Food and Drug Administration (FDA) at the confirmation hearing Tuesday despite a couple of heated questions on drug pricing and industry’s influence on him. Califf did his best to quell any concerns over industry influencing his decisions as head of the agency and the majority of senators at the hearing seemed confident that his experience makes him the right...

After reviewing the safety profile of human papillomavirus (HPV) vaccines, a European Medicines Agency's (EMA) committee found no evidence the vaccines cause two rare conditions in young women, concluding that "there is no reason to change the way the vaccines are used." PRAC Review There are currently three centrally-authorized HPV vaccines in the EU – Gardasil/Silgard, Gardasil 9 and Cervarix – to protect against cervical cancer and other HPV related conditions. Upon...

The fire stoked by rising drug prices is starting to spread through government, particularly as Sens. Susan Collins (R-ME) and Claire McCaskill (D-MO) on Wednesday announced a bipartisan Senate investigation into pharmaceutical price gouging, with letters to four companies. The letters sent Wednesday follow on the heels of HHS announcing Tuesday that it would dig into drug pricing at an invitation-only forum on 20 November. The forum will feature five panel sessions on t...

This article addresses the evolution of review systems used for advertising and promotion materials. Promotional review and approval, at its root, is designed to ensure all marketing and sales materials for pharmaceuticals are compliant with established legal, regulatory and medical standards, as well as company policies and procedures. Pharmaceutical companies employ cross-functional teams applying standard principles of education and training and good judgment to eva...