Many libertarians have expressed interest in statutes, enacted in five states, which seek to give incurably ill patients access to “investigational” drugs which have passed the first stage in the FDA’s approval process but not reached final approval. Nice goal, but according to James Beck at Drug & Device Law:
…we don’t think these statutes are going to accomplish much, let alone achieve their purpose of making investigational drugs generally available to terminally ill patients having no other choices.
One obstacle is the supremacy of the FDA:
States can pass all the laws they want, but unless the FDA gives its okay to programs more expansive than its compassionate use (“expanded access”) program, nothing’s going to happen. It’s called “preemption.”
A second is liability. While the new crop of statutes are an improvement on earlier proposals which sought to conscript pharmaceutical companies’ participation, they still give drugmakers no strong protection from resulting lawsuits, and sometimes include language hinting at the reverse. Even though plaintiff’s lawyers would face their own challenges of proving causation and damages, there would still be unknowable legal downside with relatively scant upside, making for poor incentives to participate in the program by making investigational drugs available.
That’s putting it mildly. But issues like litigation holds and charges of spoliation, and discovery generally, are where much of the action is in mass torts. Beck explains at Drug and Device Law.
The federal government has prevailed on a grand jury to indict Federal Express for servicing what it should have known were illicit online pharmacy operations. FedEx says it repeatedly asked the government to supply a list of shippers it considered illicit so that it could cut off service, but that the government refused; the Department of Justice contends that circumstantial evidence should have been enough to alert the package shipment company. Writes Mike Masnick at TechDirt: “we don’t want shipping companies to be liable for what’s in packages, because then they have not just the incentive, but the mandate to snoop through all our packages.” Amy Alkon has more on reactions. Earlier, UPS paid the government $40 million to resolve similar allegations, and Google agreed to pay a fine of $500 million for (as we put it at the time) “matching willing buyers with sellers through Canadian pharmacy ads… a forfeiture geared to the revenue the pharmacies (not it) took in from the ads.”
“Following in the footsteps of two California counties, the city of Chicago this week filed suit against five pharmaceutical companies, contending that they drove up the city’s costs by overstating the benefits of their addictive painkillers and failing to reveal the downside of taking the drugs.” [ABA Journal, Bloomberg] The city’s press release asserts, among other things: “there is no scientific evidence supporting the long-term use of these drugs [opioids] for non-cancer chronic pain.”
Suits like this are typically, though not invariably, concocted by private law firms which then pitch them to governments hoping for contingency-fee representation deals. (Orange and Santa Clara are the California counties that have signed on to such actions.) For more on the war on painkillers and their marketing, check the ample resources at Reason mag from Jacob Sullum, Brian Doherty, and others; note also a recent book, A Nation in Pain by Judy Foreman, via Tyler Cowen. Our earlier coverage is here.
Sen. Harry Reid seems to have been central:
“We felt really good the last couple of days,” said the tech lobbyist. “It was a good deal—one we could live with. Then the trial lawyers and pharma went to Senator Reid late this morning and said that’s it. Enough with the children playing in the playground—go kill it.”…
Trial lawyers are heavy donors to Democratic politicians, including Reid. … The long history of the divide over other kinds of legal tort reform loomed over the bill, which was dubbed the Innovation Act in the House. The fact that it was the trial lawyers’ lobby that reportedly delivered the death blow suggests that the rift only got wider as debate dragged on.
Key Litigation Lobby allies like Sen. Dick Durbin (D-Ill.) and Sen. Sheldon Whitehouse (D-R.I.) spoke out against the legislation on the Senate floor. [Joe Mullin, ArsTechnica]
Last week the Washington Post flayed doctors who participate in the Medicare program, along with the pharmaceutical company Genentech, because they often prescribe the $2,000-a-dose (and fully FDA-approved) eye drug Lucentis in preference to Avastin, a biologically related compound also made by Genentech that seems to work equally well against “wet” age-related macular degeneration and can be obtained off-label from compounders for only $50 an injection (albeit with some additional risks and hassles). Taxpayers have shelled out billions of dollars, the Post complains with some justice, because many docs (currently close to half) choose FDA-approved in preference to off-label treatments.
Great investigation, guys. Now that you’ve accused doctors of being socially irresponsible and greedy for not going off-label to prescribe, could you investigate who exactly has been demonizing off-label prescribing as a dangerous, unregulated practice that the FDA needs to crack down on? What would happen if you found that that it was some of the Post’s own favorite sources and advocacy groups?