Parker Waichman LLP

FDA Announces New Drug Safety Initiative

The Food & Drug Administration (FDA) is going to be giving drugs more scrutiny once they are approved and on the market.  The new policy comes as lawmakers,  concerned by the rash of recent drug recalls, have been urging the FDA to step in and implement standards to help alleviate these issues.  Also, as part […]

The Food & Drug Administration (FDA) is going to be giving drugs more scrutiny once they are approved and on the market.  The new policy comes as lawmakers,  concerned by the rash of recent <"https://www.yourlawyer.com/practice_areas/defective_drugs">drug recalls, have been urging the FDA to step in and implement standards to help alleviate these issues.  Also, as part of a larger safety initiative announced to staffers Tuesday, the FDA will strongly recommend that doctors and patients more closely follow safety guidelines when prescribing and taking medications.  This post-approval initiative was triggered by congressional action last year that broadened the FDA’s drug oversight responsibilities

This influencing of actual drug usage is a change from the FDA’s traditional role as that of monitor, or gatekeeper, for new drugs and medical products.  Up until now, the FDA developed the labels that detail how drugs are meant to be used, but it left the final prescribing decisions to doctors, who are not bound by federal guidelines and can prescribe medications for off-label—uses other than what is FDA approved—uses.  

But, now, the FDA can order drug companies to both change their drug’s labeling and conduct more safety studies on those drugs.  In the past, the FDA only had the ability to negotiate with the drug makers and was not in a legal position to compel the drug makers to make changes or implement safety studies. Congress allowed for the change and the increased authority to the FDA when several medicines—including the highly publicized issues with Merck & Co.’s Vioxx—were pulled from the market because of their safety risks to consumers.  The FDA’s commitment to more closely monitor drug use comes less than two weeks after it proposed guidelines for how medical journal articles can be used to market drugs for unapproved uses.  It is illegal for companies to promote drugs for “off-label” uses, or those uses not approved by the FDA; however, the FDA does make exceptions for medical journal reprints, which pharmaceutical salespeople often pass on to doctors.  Lawmakers have criticized that proposal as being too lenient and have argued that the proposal will allow drug companies to widely promote drugs for potentially dangerous uses.

Today, the FDA will be presenting to Congress on a post-approval initiative.  FDA Deputy Commissioner Janet Woodcock is expected to detail the “Safe Use” program at the scheduled House hearing.  The goal of shaping how doctors and patients use drugs “is a daunting but ultimately, I believe, highly rewarding objective,” Woodcock said in an e-mail sent to the FDA’s drug reviewers Tuesday.  The e-mail did not provide a great deal of information; however, Woodcock wrote that the FDA would collaborate with health care providers to “minimize medical errors and manage risks aggressively.”  In an effort to more quickly spot drug safety problems on a national level, the FDA is considering a variety of options.  One such option is a proposal that involves gathering electronic information on drug reactions from insurers and hospitals and using that information to advise physicians on prescribing decisions.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
I want to thank Parker Waichman LLP for helping me with my case. Also want to thank Ms Benita Rollis for helping me thru this time. Ms Benita Rollis is very professional and knowledgable and kept me aware of everything. Ms Benita Rollis treated my case as if it was her's. i highly recommend this law firm and Ms Rollis. thank you. .
steven rego
3 years ago
5 Star Reviews 150
Michele J at Parker waichman Was the best in helping me understand the process about the final stages of my dear fathers lawsuit settlement.mr Parker and mr waichman Michelle is extremely knowledgeable and a pleasure to deal with.my recommendation would to please let her know how thankful we are and we just wanted to let you know you definitely have a special lady working for your law firm .please let her know about my letter to you and again Michelle deserves recognition in her professionalism and knowledge.yours truly Steven Sica
Kelly Sica
4 years ago
5 Star Reviews 150
Positive: Professionalism , Quality , Responsiveness
Thomas Caragliano
3 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038