Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
| 21 November 2013 | By Alexander Gaffney, RAC
Commissioners of the US Food and Drug Administration (FDA) tend to stay at the agency for a while. Current FDA Commissioner Margaret Hamburg, for example, has been with the agency since 2009. Predecessors Andrew von Eschenbach, Mark McClellan and David Kessler were there for two, three and six years, respectively.
But unless the agency is disbanded or Hamburg is the lucky recipient of a new drug application for eternal life, she will eventually step down from her position and a new commissioner will need to be appointed by the president of the United States.
And as of 21 November 2013, the process by which a new commissioner would be appointed is now a whole lot easier.
To understand why is to understand the rules of the US Senate, one half of the US Congress and 100 members strong. Under longstanding rules, the body allows its members the ability to speak on a subject for as long as they like so long as it is relevant to the motion at hand. As a result, members can bog down the pace legislation in a process known as filibustering. While the practice has evolved considerably over the years, the threat of a filibuster is frequently used to derail both legislation and executive branch appointees.
More recently, many appointees have seen their nominations derailed due to unrelated measures, a tactic regarded by some as political hostage-taking.
For decades, the process by which a filibuster could be defeated was simultaneously simple and complex. Any two legislators could filibuster legislation (or a motion to proceed on legislation), but a vote by 60 members of the Senate could break the filibuster. As the political climate in Washington, DC has grown more acrimonious, so too has the difficulty of finding 60 votes to break many filibusters increased.
On 21 November 2013, Senate Democrats, led by Majority Leader Harry Reid (D-NV), exercised a long-threatened "nuclear option" in the Senate and voted by simple majority to change the rules of the filibuster.
Under the new rules, any judicial or executive branch appointee will be insulated from filibustering and would be approved by a simple majority vote (51 votes).
The rule change would most notably impact the practice of senators placing informal "holds" on nominees, which are generally used to extract more information about candidates but have also been used as a delaying tactic in other cases. The practice was largely contingent upon the ability of senators to filibuster a nominee, but with that power now gone, it would appear that the practice will be no more.
As a result, future appointees to the position of commissioner of FDA-an agency that is no stranger to areas of controversy like birth control-will likely have an easier time clearing the Senate. At least one FDA commissioner, Lester Crawford, was subject to the threat of holds.
Tags: Senate, Congress