Drug Companies Support Splitting the FDA, But For the Wrong Reasons?

Add drug companies to the growing list of those who want to split the U.S. Food and Drug Administration in two and create a new federal agency to regulate new drugs and medical devices. But is the pharmaceutical industry’s heart in the right place?

Members of Congress, consumer rights advocates, and others have said they support reassigning the duties of the FDA because they think doing so would improve the safety of the nation’s food supply or make the agency more efficient and cost effective. President Barack Obama has said reorganizing the FDA’s duties is a priority for his new administration and that creation of a new federal agency to oversee new drugs and medical devices, freeing up the FDA to focus solely on food safety, is a possibility.

Obama recently appointed two public health specialists to the agency’s top positions and named an advisory group to reassess the nation’s decades-old food safety laws, raising hopes that a major overhaul of the FDA is coming.

Faster Drug Approvals

However, drug industry officials who are quietly voicing support for an FDA split are doing so hoping that such a move would speed up the approvals process for new-drug applications. In recent years, the pace of approvals for new drugs has slowed as a slew of new products have flooded the FDA seeking the go ahead.

By taking the drug-approval process away from the FDA and placing it with a new agency solely charged with that duty, drug companies are hoping they would enjoy faster consideration of new drugs and medical devices.

For anyone who has been injured or had a loved one killed by defective drugs or medical devices, the thought of speeding up the FDA approvals process probably doesn’t sound like a good idea. Many consumer advocates contend that the current system of reviewing and approving proposed drugs already is deeply flawed by conflicts of interest, secrecy, and other policies that mean dangerous drugs and medical products are given to patients.

What would be the result if the drug companies get their way and new drugs are rushed through an expedited approvals process? It’s hard to imagine the result would be good for millions of drug consumers.

Legislation to Overhaul FDA on the Way

Several lawmakers have said they support reworking the FDA to separate the agency’s current duties and allowing the FDA to focus solely on regulating the nation’s food supply.

Rep. Rosa DeLauro (D-Conn.) has said she favors consolidating food regulation by combining the FDA and the U.S. Dept. of Agriculture (USDA). The new agency would be given the power to order recalls and increase food inspections.

Meanwhile, Sen. Dick Durbin (D-Ill.) is sponsoring a bill which would expand the scope of the FDA and increase its budget by $775 million to support increase inspections and heightened regulations.

We Must Proceed With Caution on FDA Split

For years, the FDA has been criticized for failing to prevent or respond quickly to outbreaks of food-borne bacteria, such as salmonella linked to tainted peanut butter, spinach, tomatoes, and peppers. The call to reform the embattled agency has now, with the election of President Obama, reached a fevered pitch and a spot near the top of the White House agenda.

However, while swift and dramatic changes to the current system might seem like the best way to quickly improve the FDA, such action could have far-reaching consequences. Faster drug and medical device approvals are not the reason why the FDA should be overhauled. In the end, consumers will suffer from having a streamlined approvals process. More defective and dangerous drugs and products will slip through the cracks if the review and approvals process is sped up, but drug companies will profit from getting more products passed.

President Obama and other leaders must make sure to get the task of reworking the FDA right and not at the expense of millions of American drug consumers.

No related posts.