Pharma’s Bogus Case Against the CREATES Act

Big Pharma’s trash fire of lies seems to rise ever higher each day.

On one level, this is thoroughly unsurprising. For the first time in an eon, one of D.C.’s most protected industries is feeling some heat. Egged on by a price-skeptical president, bipartisan coalitions in Congress have formed around the cause of lowering drug prices, and unlike so many other attempts to address the problem, these coalitions appear to have the will to succeed.

But one would think that even an industry backed into a corner might have some small vestige of shame about the stories it peddles. Apparently, when it comes to pharma’s crusade against at least one piece of legislation, this is too much to ask.

That piece of legislation is the CREATES Act, a bill sponsored by conservative stalwart Sen. Mike Lee (R-UT) and recently reintroduced by the same. The bill has been, throughout its various incarnations, praised by economists for its conscientious but tough approach to the drug pricing issue.

Specifically, the bill aims to make it easier for generic drug manufacturers to gain samples of off-patent drugs by cracking down on pharma’s previously expansive power to deny access to such samples on dubious grounds. It does this by permitting generic drug manufacturers who have cleared FDA approval to sue non-cooperative brand name manufacturers for access to their drugs. In short, it’s a home run for sick patients and for the free market.

Needless to say, Big Pharma hates it. And in order to preserve its ability to act as ruthless gatekeepers against competition, the industry has trotted out a whole series of lies about the bill, some of which wouldn’t even pass the laugh test if they weren’t cloaked in impenetrable wonk-speak.

To start with, pharma’s defenders argue that the bill weakens protections for patients and researchers who enter clinical trials conducted by generic manufacturers. They claim that these manufacturers can simply demand samples of drugs and then do what they like with them, safety and protocol be damned.

This is (no pun intended) patent nonsense. The bill explicitly requires any generic manufacturer who wants access to drug samples for the purposes of trials (or anything else) to first get approval from the FDA. Further, it leaves every safety protocol used by the FDA in place, despite many of those protocols being vulnerable to criticism for being anticompetitive (as President Trump noted in his recent address to Congress). A gift to Dr. Frankenstein this ain’t.

Pharma’s defenders further attack the bill for supposedly not ensuring FDA oversight will be sufficient before permitting generic drug manufacturers to demand samples through the legal system. Yet why should it? Existing law and FDA regulations already provide for this kind of oversight, and the CREATES Act, as already mentioned, makes no effort to weaken that law or those regulations. In essence, this attack is comparable to a carriage manufacturer impugning automobiles for failing to reinvent the wheel.

Not content with this stinker, pharma moves on to suggest that the bill forces the FDA to intervene on behalf of generic manufacturers who request samples after 90 days, regardless of whether those manufacturers live up to the FDA’s standards. Actually, the bill merely requires the FDA to act after 90 days — to intervene on behalf of the generic manufacturer or to decline to do so. I grow weary of repeating this, but as far as the CREATES Act is concerned, all the FDA’s existing safety measures are preserved in amber.

Finally, in what may be the silliest lie of the bunch, pharma claims that the CREATES Act strips power to adjudicate from the FDA and hands it over to the courts. One wonders if its people even read the bill before making this argument. Yes, generic manufacturers can sue for access to off-patent brand name drugs, but if and only if their plans for developing those drugs in generic form pass muster with the FDA first. In other words, if the FDA says no at any point, the whole lawsuit process is short circuited. Do not pass go. Do not collect 200 capsules. This is, ironically, the very thing that the pharmaceutical industry claims to want out of this process, yet apparently when their power to act as monopolists is even slightly threatened, they can’t take yes for an answer.

Bad faith accusations are nothing new for Big Pharma. It’s been using similar lies to try to undermine pro-patient reforms like drug re-importation or the 340B drug pricing program for years. Nevertheless, one hopes that, with Senator Lee’s name on the CREATES Act and with President Trump committed to a more pharma-skeptical Republican policy, this time the lies might sound a little too… well… generic to pass muster.

Sign Up to receive Our Latest Updates! Register