Trump’s Proposed Changes Gut FDA While Targeting Drug Prices

Jay W. Belle Isle, Legal Reader

As I sit here writing, I have to wonder how much of this post will be true tomorrow. We have a saying in Michigan: “Don’t like the weather? Wait five minutes, it’ll change.” The saying seems to fit the new administration, too. Changes – and executive orders – are flying around at the speed of light.  Trump met with some of the world’s biggest Big Pharma executives Tuesday of this week. His message was pretty clear: lower drug prices, bring jobs back to the U.S., and he’ll gut the already weakened FDA, doing away with those pesky regulations that barely keep the American people safe now.

How comforting. If successful, we may as well start calling the FDA the Former Drug Agency.

The execs in attendance at this diabolical gathering came from Johnson & Johnson, Celgene Corporation, Eli Lilly & Company, Merck & Company Inc., Novartis AG (a Swiss company) and the chief of the Pharmaceutical Research and Manufacturers of America (PhRMA), the industry’s puppet lobbying group, among others. PhRMA is behind the plan for a multi-year, multi-million dollar ad campaign aimed at justifying increases to drug prices. One wonders if PhRMA will cancel this foolish waste of time and money following this meeting.

During the meeting, Trump said, “So you have to get your companies back here. We have to make products … We have to get rid of a tremendous number of regulations. I know you have some problems where you cannot even think about opening up new plants. You can’t get approval for the plant and then you can’t get approval to make the drugs. We have no choice. For Medicare, for Medicaid, we have to get prices way down, so that’s what we’re going to be talking about. We’re also going to be streamlining the process so that from your standpoint so that when you have a drug you can actually get it approved — if it works — instead of waiting for many, many years.”

The CEOs who jumped on the opportunity to highlight their long histories in the U.S. and all of the U.S. plants they have and a story in the Wall Street Journal states that over half of the drugs sold in the U.S. are made here. However, according to the WSJ, most of the raw ingredients in those drugs come from places such as India and China. It has been pointed out that regardless of a drug’s country-of-origin, its manufacturer must adhere to U.S. regulations to be sold here. Essentially, that means Big Pharma has to meet U.S. regulations for drugs made here or abroad. So, the only reason for moving jobs overseas is basically a boost to Big Pharma’s bottom line in the form of less taxes, etc.

A bit of tension still exists between the Commander-in-Chief and Big Pharma. Drug prices. While he hopes the industry will respond favorably to his offer to lower taxes and gut the FDA, Trump also added that he’s willing to whip out the pen and correct the problem with drug prices himself if needed. This could include letting Medicare negotiate drug prices with the industry, an idea that Big Pharma despises with all of its corporate greed.

Dr. Diana Zuckerman, president of the National Center for Health Research, an organization that works for strong safety and effectiveness standards in the industry said, “Streamlining drug approvals sounds good, but the agency has already weakened approval standards and patients are paying the price — hugely expensive drugs that don’t even work.”

Dr. Zuckerman has done her homework, too. In a study published on the JAMA Network, Dr. Zuckerman and her co-author, Tracy Rupp, looked at certain new – and expensive – cancer drugs. They found that many of these drugs failed to improve patient quality of life or extend patient life.

Read the full article here.