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Trump’s Proposed Changes Gut FDA While Targeting Drug Prices


— February 2, 2017

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.


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. Frankly, I think the comedians on SNL got a better deal than we who report on the news. But, report we do; laugh, especially at this news, we do not. 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.”

He backed that up with informing the Big Pharma big wigs that the administration plans to cut “regulations at a level no one has ever seen before.”

I feel safer already, don’t you?

Trump also said, “We’re going to streamline the FDA, we have a fantastic person that I think I we’ll be naming fairly soon, he’s going to streamline the FDA and you’re going to get your products either approved or not approved but it’s going to be a quick process. It’s not going to take 15 years. And we’re going to do I think a tremendous — I think we’re going to make a tremendous difference to you. I read where it costs sometimes $2.5 billion on average, actually, to come up with a new product. Is that correct? 15 years, $2.5 billion to come up with a product where there’s not even a safety problem. So it’s crazy. I’m surprised you can’t get them to move faster than that.” [Emphasis added by the author, typos in the original]

One finds it disturbing that the man making these sweeping decisions “read where it costs…” and then had to ask the CEOs if it was true. Whatever happened to informed leaders who did their homework? Even more disturbing is him saying “15 years, $2.5 billion… where there’s not even a safety problem.” What? In response to that asinine assertion, I wanted to link to other articles pointing out just how many safety problems there are with pharmaceuticals and how the regulations we have now aren’t doing enough to protect us. Then, I realized the sheer number of links that would entail. Suffice to say, if you want to see the degree of the problem, search this blog for “Essure” or “Taxotere” or “Testosterone” or… you get the idea. A word of advice: plan for several hours of reading and prep a meal or two.

In a moment of what I’ll call compassion, Trump said, “One thing that’s always disturbed me is that you come up with a new drug for a patient that’s terminal and FDA says you can’t have this drug used on this patient and patient will be dead… we don’t know if drug works or doesn’t work, but the patient’s not going to live for more than 4 weeks.”

I’ll call it compassion and part of it may be, but what it seems to be is a lack of good information. According to the Regulatory Affairs Professionals Society (RAPS), the comment referred to the FDA’s current “compassionate use or expanded access” program, which works to help the terminally ill patients Trump mentioned. Just last year, the Agency created an expedited process to address that issue.

RAPS points out, however, that experts have stated the real problem is not FDA delays. The Agency approves over 99% of the requests it gets for expanded access. It’s the Big Pharma firms themselves who limit access to terminally-ill patients, because “often times, requests for early access to a developing drug are denied because the patients don’t meet certain criteria established by the company running the trial,” according to RAPS.

Trump stated that, “Instead of it being 9,000 pages, it’ll be 100 pages,” referring, many think to the FDA’s regulations, guidance and rulemakings. One certainly hopes these are off-the-cuff numbers, otherwise we are all in big trouble. He did go on to say that he plans to dispose of 75% – 80% of the Agency’s regulations, though.

He also mentioned the lack of foreign regulations, though not in great detail. “It’s very unfair what other countries are doing to us, a lot of that has to do with regulation. Other countries have no regulation and you go there for that reason.” In other words, U.S. safety regulations are to blame for Big Pharma moving jobs overseas.

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.

What do other drug safety advocates have to say about this meeting and its potential outcomes?

Dr. Michael Carome, the director of Public Citizen’s health research group said, “Trump’s horrifying proposal reflects utter ignorance about the F.D.A.’s essential role in protecting public health and once again demonstrates his commitment to placing corporate profits above protecting the safety of the American people.”

Commenting on the removal of those regulations which had been established by Congress, Dr. Carome continued, “Most of these regulations, to do away with them would require new statutes and new laws to be passed.”

Oh, if only that were true. Despite criticism of Obama’s use of the executive order, Trump has had no problem bypassing Congress using that same vehicle.

The National Center for Health Research homepage; image courtesy of www.center4research.org.
The National Center for Health Research homepage; image courtesy of www.center4research.org.

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.

Senator Bernie Sanders (D-VT) and Representative Elijah Cummings (D-MD) joined together in a statement following Trump’s Big Pharma meeting. In the statement, they expressed their hope that Trump “really” tackles Big Pharma, specifically regarding drug prices. They also said they plan to introduce legislation that would lower prescription drug prices. The legislation would also permit Medicare to negotiate for lower drug prices, something that Trump also supports.

Stay tuned.

Sources:

Trump pushes drugmakers for lower prices, more U.S. production
Trump pledges to work with Big Pharma to lower drug prices
Trump to Pharma CEOs: 75% to 80% of FDA Regulations Will be Eliminated
Trump Vows to Ease Rules for Drug Makers, but Again Zeros In on Prices
President Trump Works To Make Drugs More Affordable, Create Jobs

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