Justinian Lane

The tort reform movement is right. Lawyers are keeping needed drugs off the market.

The tort “reform” movement often argues that personal injury lawyers and lawsuits keep needed drugs from reaching the marketplace.  It turns out they’re half right.  Lawyers are keeping drugs from the market, but it’s the pharmaceutical industry’s lawyers – and not personal injury attorneys - that are doing it:  

The Federal Trade Commission has filed suit in federal court in an attempt to block a deal in which a manufacturer of a brand-name testosterone-replacement drug paid three competitors to delay rolling out cheaper generic versions.

The FTC said the "pay-for-delay" agreement violates antitrust laws, robs consumers of less-expensive alternatives and allows the brand-name drugmaker an unfair monopoly. The state of California joined the federal agency in its complaint, which was filed last week in U.S. District Court in the Central District of California.

Source: FTC Sues in 'Pay-for-Delay' Pact -- Drugmaker Paid Rivals to Keep Generic Off the Market, Agency Says -

More on the story at CNN and at FiercePharma.

When I hear a “reformer” argue in favor of FDA preemption because lawsuits might be keeping drugs off the market, I have an easy litmus test to see if he or she is concerned for public safety or is merely a corporate lackey who is paid to parrot the party line: I ask how he or she feels about “pay to delay” deals.

I would also answer the following rhetorical question by pointing to “pay to delay” deals:

[Pfizer Global PR Chief Ray] Kerins finds it incredible that despite making products designed to save lives and cure diseases, the drug industry enjoys such low esteem among the public. "How in the hell do we have such a bad reputation?" was his way of expressing it. "It makes no sense."

Source: Pharma Marketing Blog: Pfizer's PR Chief: "How in the hell do we have such a bad reputation?"

The fact that pharmaceutical companies enter into agreements with competitors to keep drugs off the market shows that those companies care far more about profits than they do about patient safety.  And it’s disingenuous to the extreme for those same companies to argue in favor of preemption on the grounds that lawsuits keep needed drugs off the market. 

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Posted at 12:30 PM, Feb 05, 2009 in Pharmaceuticals
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You have as your title "Lawyers are keeping needed drugs off the market." Where is this the case? The actual issue is pay-for-delay. Also, what does "preemption" have to do with this. This is a business matter in which one firm is accused of paying another to delay release of a generic. What does this have to do with patient safety?

Posted by: throckmorton | February 6, 2009 8:05 AM

Who do you think drafts the pay-to-delay agreements? Pharmaceutical company lawyers.

What it has to do with preemption is expose hypocrisy: If failure to warn lawsuits are "bad" because they keep drugs off the market, then pay-to-delay agreements are also "bad" for the same reason.

And what it has to do with patient safety should be obvious... unless you think that widespread availability of cheap generics isn't good for patient safety.

Posted by: Justinian Lane | February 6, 2009 9:52 AM

I am actually concerned with the widespread availability of cheap generics. The reason is simple, for these new medications, the gererics are not that cheap. Further, we are seeing conterfeit medications. Admittedly these are coming in from Mexico and Canada but are becoming more and more of a problem.

Pay to delay arguments do not keep drugs off the market, they just affect who gets to sell them. The pharmaceutical lawyers who draft the agreements do not delay the drugs, in fact, if they delayed the sale of drugs I bet they would not be working for the pharmaceutical company.

I think that your cited article does not support your claims. If you want to sue someone for delaying medications, I suggest you sue the FDA and the politicians who control it. There are many cancer medications that are approved in Europe that we can not use here. Patients are passing away because of the present policy.

Posted by: throckmorton | February 6, 2009 2:24 PM

Not to split hairs with you, but if an agreement is keeping a generic medication off the market, it isn't just "affecting who gets to sell them." Those agreements are keeping entirely new drugs off the market.

I'd also have to disagree with you about the cheapness point. Many generics are $4 bucks for a month's supply. Few name brands are. If you want to suggest that the generics aren't biologically equivalent, or are more prone to be counterfeit, I'll listen... but you'll have a very hard time selling me on the idea that a $4 dollar a month drug isn't cheap.

I'm very sympathetic to the plight of those people who can't get access to unapproved drugs. I personally have no issue with letting people take whatever the hell drug they want, approved or not. The problem is that I don't want to pay for the side effects of those drugs. If for example an unapproved drug causes a heart attack, taxpayers may have to pay (through Medicaid & Medicare) $100k+ in medical bills. We as a nation aren't comfortable with letting someone "opt out" of those programs and then die in the street if their unapproved drug causes trouble.

If people are willing to let the government pay for their healthcare, they must also accept limitations on what the government will let them take.

Posted by: Justinian Lane | February 7, 2009 10:29 AM