Schedule a Consultation: (973) 274-5200
Social Accounts Sprite

FDA Draft Guidance Sparks Debate

By Paul da Costa on March 26, 2015


Last June, the FDA released a draft guidance that would permit drug manufacturers to provide additional information to doctors regarding the risks of particular drugs.  The guidance allows manufacturers to circulate information that refutes the risks listed on a drug’s warning label.  The Wall Street Journal recently reported that the draft guidance has launched a debate between those who support free speech and those who advocate for patient safety. 

Manufacturers support the guidance because it provides physicians with novel information about a drug, particularly in light of the fact that knowledge about a drug’s risks evolves as it is more frequently prescribed.  In addition, the First Amendment counsels that drug manufacturers should have the right to disseminate information freely. 

In contrast, critics argue that the guidance could cause harm to patients as drug manufacturers refute the risks associated with using particular drugs.  Opponents also say that the guidance simply helps manufacturers in a financial sense at the expense of patient safety.

While the FDA is still considering the response to the draft guidance, it is unknown how the FDA will ultimately act.  If the guidance is adopted as a regulation, there may be more injuries caused by pharmaceutical drugs than before. 

If you or a loved one was injured by a prescription drug or medical device, you may have a personal injury claim to obtain just compensation for your harm.  Call Paul M. da Costa, Esq. at Snyder & Sarno, LLC at (973) 274-5200 to discuss your case. 

Related to This

Message Us

"I was involved in a VERY complicated and tumultuous child custody, divorce, domestic violence case for two full years. I was fortunate enough to be represented by one of the top matrimonial teams in the state of NJ, and the outcome in my case exceeded my every expectation." - Former Client

"Paul personally stood by my side and represented me throughout my injury case. Whether it was business at hand, advice, or a late night phone call to help me understand what was going on; he never took a step back towards helping me. I knew that I could call on him at any time . My case was very successful and I attribute that to Paul's dedication . He even came to me during a snow storm when I could not make it to his office. I certainly would recommend him to anyone." - Former Client

X CLOSE

Bergen County Office

401 Hackensack Ave
Ste 706
Hackensack, NJ 07601

Open Today 8:30am - 5:30pm

Essex County Office

425 Eagle Rock Ave
Ste 202
Roseland, NJ 07068

Open Today 8:30am - 5:30pm

Somerset County Office

440 Route 22 E
Ste 170
Bridgewater, NJ 08807

Open Today 8:30am - 5:30pm

X CLOSE

Message Us

X CLOSE

X CLOSE

Popular Tags