regulatory affairs

FDA Advisory Committee Preparation Tips

FDA Advisory Committee Preparation Tips

Whether you are a target of  regulatory hearing or your industry is the focus, being prepared is important to any successful outcome.  

Today's legal market demands broad business solutions

Today’s legal market demands a broad range of business solutions lawyers can provide their clients. A strategic communications plan can prove to be an extremely helpful tool law firms can provide their clients. For example, in today’s 24/7 media culture, companies lack access and lack control to the media who cover their industry and to the people that talk about them on-line. In addition, businesses often find themselves navigating a complex environment that requires dealing simultaneously with litigation, governmental and regulatory actions, media scrutiny, and public perception. Often times, business strategy demands a multi-disciplinary approach of legal action, public relations and government relations. Knowing where these issues converge can help protect your reputation and enhance your position in the marketplace.

For example, last week, an article in the Michigan Lawyer's Weekly unveiled new court rules directing the jury not to Twitter about the case before them or turn to the Internet for information beyond that which was presented to them in the court. Social media is not only becoming some thing for us to stay in touch with friends, it is becoming a new area to look out for our clients interests and/or a new medium to promote our practice.

Also, in just seven months a number of key bills have been enacted by Congress and President Obama, including: The economic stimulus package; Expansion of SCHIP; Pentagon acquisition reforms; & other key reforms. Congress returned this week to tackle a number of difficult issues, before their August recess, including: Energy & Climate legislation; Health Care Reform; FY 2010 Appropriations; Reauthorization of the transportation bill; Financial regulation; food safety, and Immigration reform.

Attorneys in high-profile cases should extend their services beyond the courtroom and in the court of public opinion. Therefore, lawyers will need skilled advice as to how to position their clients before the media or in front of the legislature, while protecting their legal rights.

Seeking PR counsel is an important aspect of representing clients in high-profile cases. Even if the issue is a small matter, there is no way we can tell how public opinion can or will shape the outcome of a case. Therefore, in engaging PR Counsel:

Have the lawyer retain the PR firm as opposed to your client directly, to try to preserve attorney-client privilege;

The PR counsel should consult with the client, only in the presence of an attorney and first talk things over with the attorney to seek their support and buy-in for the PR strategy.

Once a PR firm is engaged, they will (depending on the strategy): Asses the situation, review any media to date;

Create key messages;

Create talking points for key audiences including, staff, vendors, clients and the media;

Using the key messages, educate and sensitize the media to mitigate damage or control the story;

Facilitate interviews; and,

Provide media/spokesperson training.

“An attorney’s duties do not begin inside the courtroom door. He or she cannot ignore the practical implications of a legal proceeding for the client." See Gentile v State bar of Nevada (Kennedy opinion) 510 US 1030, 1043 (1991). Just as an attorney may recommend a plea bargain or civil settlement to avoid the adverse consequences of a possible loss after trial, so too an attorney may take reasonable steps to defend a client’s reputation…in the court of public opinion

In today’s fast-paced environment, where it may take years to build up one’s reputation and only seconds to destroy it, a lawyers role as advocate extends to managing their clients’ reputations inside and out of the courtroom.