The recent court decision by the full D.C. Circuit Court of Appeals (reversing an earlier decision by its own three-judge panel) ruled 8-2 against the Abigail Alliance for Better Access to Developmental Drugs' effort to enshrine as a constitutional right a patient's access to unapproved investigational (non-FDA-unapproved) medicines.
Now, before going any further, it's important to point out that there's been a lot of very heated rhetoric on both sides of the issue. And this shouldn't come as a surprise since this is, in the most literal sense, a matter of life and death.
But over-heated rhetoric generally means that each side demonizes the other and neither is listening.
Nobody believes expanded access to drugs under clinical investigation is a bad idea. That's precisely why, when I was at the FDA, we stopped calling such programs "compassionate use." That outdated phrase makes it sound like the FDA and/or any given pharmaceutical company is doing the patient a favor by "being compassionate." Now don't get me wrong, being compassionate is an admirable trait -- but allowing desperately ill patients into clinical trial programs shouldn't be an act of good will, it should be an act of civil society.
But there has to be oversight. There has to be a responsible body that sets rules. Libertarianism, when it comes to pharmaceutical safety, isn't in the best interests of the public health. Does that mean the status quo works? No.
The FDA has proposed changes to address this issue. Do they go far enough? No. Does that mean "expanded access" should morph into "total access" to experimental drugs? No.
In short, there is no black-and-white/right-wrong answer to this question. But that's not what many folks on both sides of the argument are saying.
The FDA needs to reconsider how it can broaden and facilitate expanded access to experimental drugs beyond the current state of affairs (and the state of pending rules). And the Abigail Alliance and their supporters need to keep up the pressure (legal and otherwise) -- but remember they must also work within the system.
Both sides want the same thing -- expedited expanded access programs. But name calling and bridge burning doesn't bring anyone closer together or experimental drugs to dying patients any faster.
Now, before going any further, it's important to point out that there's been a lot of very heated rhetoric on both sides of the issue. And this shouldn't come as a surprise since this is, in the most literal sense, a matter of life and death.
But over-heated rhetoric generally means that each side demonizes the other and neither is listening.
Nobody believes expanded access to drugs under clinical investigation is a bad idea. That's precisely why, when I was at the FDA, we stopped calling such programs "compassionate use." That outdated phrase makes it sound like the FDA and/or any given pharmaceutical company is doing the patient a favor by "being compassionate." Now don't get me wrong, being compassionate is an admirable trait -- but allowing desperately ill patients into clinical trial programs shouldn't be an act of good will, it should be an act of civil society.
But there has to be oversight. There has to be a responsible body that sets rules. Libertarianism, when it comes to pharmaceutical safety, isn't in the best interests of the public health. Does that mean the status quo works? No.
The FDA has proposed changes to address this issue. Do they go far enough? No. Does that mean "expanded access" should morph into "total access" to experimental drugs? No.
In short, there is no black-and-white/right-wrong answer to this question. But that's not what many folks on both sides of the argument are saying.
The FDA needs to reconsider how it can broaden and facilitate expanded access to experimental drugs beyond the current state of affairs (and the state of pending rules). And the Abigail Alliance and their supporters need to keep up the pressure (legal and otherwise) -- but remember they must also work within the system.
Both sides want the same thing -- expedited expanded access programs. But name calling and bridge burning doesn't bring anyone closer together or experimental drugs to dying patients any faster.
