On September 23, 2005 we blogged on a grandstanding measure put forward in the DC City Council by David Catania — a lawyer at the mega-DC firm of Akin, Gump, Strauss, Hauer, Feld (“What does DC stand for?â€).
(Mr. Catania is also known by many inside-the-Beltway as “Rahm Emanuel, Jr.")
At the time Councilman Catania was calling for pharmaceutical price control legislation in the District of Columbia (since overturned in court). This prompted drugwonks to ask just what “DC†stood for. We posited that it stood for “drug catastrophe.â€
Well, Mr. Catania is at it again.
This time he’s proposing the District of Columbia “Safe Rx Act of 2007.†Besides the fact that many of its provisions are illegal (perhaps Mr. Catania should have asked one of his junior associates to do some background work), what’s most important is that the bill is contrary to both the public health and to common sense.
In other words, it’s all about politics.
I know – shocking.
Some sample content:
* Any person who educates physicians without a license shall be subject to a fine of $10,000. (This is in the section that calls for the licensing of pharmaceutical representatives.)
What about free speech, Mr. Catania? Were you absent during that law school lecture? And what about the fact that the FDA already regulates all educational efforts between physicians and sales reps? Inconvenient truths.
Also, nothing in the bill requires that evidence based “detailers†be held to any of the same standards as pharmaceutical representatives.
* The DC Department of Health will create a “Pharmaceutical Education Fund†for the “sole purpose of establishing and funding an evidence-based research, outreach, and education program within the DC DoH designed to provide information on the therapeutic and cost-effective utilization of prescription drugs.
Gadzooks, a DC DERP. Gee – I wonder who Mr. Catania has been talking to inside the majority Congressional leadership. Do the people of the District of Columbia really want cost-based rather than patient-centric care by statute?
* Pharmaceutical companies must disclose specific information on any clinical trials related to any drug or biologic product sold, delivered, dispensed, offered for sale, or given away in the District.
Oops again. Looks like Mr. Catania missed The FDA Amendments Act of 2007 (FDAAA), passed in September 2007, which expands the existing federal clinical trial registry administered by NIH by including more trials, more comprehensive information on each trial, and establishing a clinical trial results databank
Once rules for the federal expanded clinical trial registry and results database are promulgated the federal law will preempt any state clinical trial registry or results requirements.
Sloppy legal prep, counselor.
* Pharmaceutical companies must provide DC with FDA correspondence.
Um, all warning and untitled letters are already posted on the FDA website. But, hey, demanding such already publicly available letter it makes for good headlines, right?
Here’s my favorite …
* The bill requires prescribers to obtain written informed consent from patients when prescribing a prescription medication for a medically accepted indication.
So much for the concept of the “learned intermediary.â€
And as far as off-label use is concerned …
* Prescriber must explain to the patient that the medication is being prescribed outside of the indications for that medication as approved by the FDA and provide the patient with information commonly known by the medical profession regarding potential risks and side-effects
Um, according to the Medicaid statute medications prescribed for a medically accepted indication may only be restricted if, based on the compendia, the drug does not have a significant, clinically meaningful therapeutic advantage in terms of safety, effectiveness, or clinical outcome.
So much is wrong about so many things in this bill that it makes H.R. 380 (Rahm Emanuel’s “Pharmaceutical Market Access and Drug Safety Actâ€) look like the next coming of the Magna Carta.
“DC†may mean “David Catania,†but it mustn’t be allowed to mean “Drug Catastrophe†-- again.
(Mr. Catania is also known by many inside-the-Beltway as “Rahm Emanuel, Jr.")
At the time Councilman Catania was calling for pharmaceutical price control legislation in the District of Columbia (since overturned in court). This prompted drugwonks to ask just what “DC†stood for. We posited that it stood for “drug catastrophe.â€
Well, Mr. Catania is at it again.
This time he’s proposing the District of Columbia “Safe Rx Act of 2007.†Besides the fact that many of its provisions are illegal (perhaps Mr. Catania should have asked one of his junior associates to do some background work), what’s most important is that the bill is contrary to both the public health and to common sense.
In other words, it’s all about politics.
I know – shocking.
Some sample content:
* Any person who educates physicians without a license shall be subject to a fine of $10,000. (This is in the section that calls for the licensing of pharmaceutical representatives.)
What about free speech, Mr. Catania? Were you absent during that law school lecture? And what about the fact that the FDA already regulates all educational efforts between physicians and sales reps? Inconvenient truths.
Also, nothing in the bill requires that evidence based “detailers†be held to any of the same standards as pharmaceutical representatives.
* The DC Department of Health will create a “Pharmaceutical Education Fund†for the “sole purpose of establishing and funding an evidence-based research, outreach, and education program within the DC DoH designed to provide information on the therapeutic and cost-effective utilization of prescription drugs.
Gadzooks, a DC DERP. Gee – I wonder who Mr. Catania has been talking to inside the majority Congressional leadership. Do the people of the District of Columbia really want cost-based rather than patient-centric care by statute?
* Pharmaceutical companies must disclose specific information on any clinical trials related to any drug or biologic product sold, delivered, dispensed, offered for sale, or given away in the District.
Oops again. Looks like Mr. Catania missed The FDA Amendments Act of 2007 (FDAAA), passed in September 2007, which expands the existing federal clinical trial registry administered by NIH by including more trials, more comprehensive information on each trial, and establishing a clinical trial results databank
Once rules for the federal expanded clinical trial registry and results database are promulgated the federal law will preempt any state clinical trial registry or results requirements.
Sloppy legal prep, counselor.
* Pharmaceutical companies must provide DC with FDA correspondence.
Um, all warning and untitled letters are already posted on the FDA website. But, hey, demanding such already publicly available letter it makes for good headlines, right?
Here’s my favorite …
* The bill requires prescribers to obtain written informed consent from patients when prescribing a prescription medication for a medically accepted indication.
So much for the concept of the “learned intermediary.â€
And as far as off-label use is concerned …
* Prescriber must explain to the patient that the medication is being prescribed outside of the indications for that medication as approved by the FDA and provide the patient with information commonly known by the medical profession regarding potential risks and side-effects
Um, according to the Medicaid statute medications prescribed for a medically accepted indication may only be restricted if, based on the compendia, the drug does not have a significant, clinically meaningful therapeutic advantage in terms of safety, effectiveness, or clinical outcome.
So much is wrong about so many things in this bill that it makes H.R. 380 (Rahm Emanuel’s “Pharmaceutical Market Access and Drug Safety Actâ€) look like the next coming of the Magna Carta.
“DC†may mean “David Catania,†but it mustn’t be allowed to mean “Drug Catastrophe†-- again.
