Category Archives: Schering generic threats FDA non-approvable letter Apri

Probably this wasn’t ever going to "move the needle" very much at Schering, but. . . .

. . . .this is plainly a disappointment for the Fred Hassan/Schering-Plough strategy of taking older, mature-market drugs, and re-igniting them by combining them with another active agent. [Think of Vytorin’s marrying of Zocor with Zetia, here.] While the company said it was “evaluating its response” to the non-approvable letter from FDA, it probably means a[nother] write-off of at least $50 million in development costs, ad pitch consulting and strategy materials, etc. associated with the combo’s one-and-one-half-year journey from FDA submission (August 2007), to last night.

I wonder whether the letter is also a harbinger of things to come at FDA: is this the beginning of a new — more skeptical — FDA review and approval process, when the clinical benefits of these combos appear marginal (as compared to taking the two drugs as two separate footballs), but the protections against patent-expiry, or generic incursions, seem to be one of the company’s main motivating factors for submitting an ANDA?

I think it likely. Of course, Pharmalot’s Ed Silverman has an even wider, and more cogent, meta-narrative he points us to, this morning — and I think he is largely right. Brilliant, that one (though, Ed, isn’t photocopying US currency, at least theoretically. . . . still a Class B felony? Heh!).

I do think, insofar as meta-narratives go, this is additional proof1 that the pendulum at FDA is swinging toward “slow to approve/quick to issue warning letters” — [as to Schering, then, think about a slower path for its Sugammadex product, even though it holds an FDA “approvable” letter, at the moment — it is not yet “FDA approved“] and thus, relatively-speaking, away from where it had been for a good portion of the two Bush/Cheney administrations.

~~~~~~~~~~~~~~~~~~~~~~~~~

[Footnote 1: I’ll note in passing that FDA drug unit chief Woodcock, and Baxter CEO Bob Parkinson, will appear before a Congressional Committee, at a hearing provocatively-entitled “The Heparin Disaster: Chinese Counterfeits and American Failures“, on this coming Tuesday, to explain how it was that, between FDA inspections of the wrong Chinese supply-plants, and Baxter’s filling and packaging operations (in reliance on various global suppliers, of course) — the batches of Heparin (both the Baxter-versions, and the competitors’ versions) got contaminated, in the first place, shipped into hospitals, in the second place, and injected (or dripped) into the IV lines of patients, in the final analysis. Which is to say, I think it likely that the legislative/investigatory pressures from Sen. Grassley, and Reps. Dingell and Stupak, will not abate — and FDA is adjusting its course, accordingly.]

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Probably this wasn’t ever going to "move the needle" very much at Schering, but. . . .

. . . .this is plainly a disappointment for the Fred Hassan/Schering-Plough strategy of taking older, mature-market drugs, and re-igniting them by combining them with another active agent. [Think of Vytorin’s marrying of Zocor with Zetia, here.] While the company said it was “evaluating its response” to the non-approvable letter from FDA, it probably means a[nother] write-off of at least $50 million in development costs, ad pitch consulting and strategy materials, etc. associated with the combo’s one-and-one-half-year journey from FDA submission (August 2007), to last night.

I wonder whether the letter is also a harbinger of things to come at FDA: is this the beginning of a new — more skeptical — FDA review and approval process, when the clinical benefits of these combos appear marginal (as compared to taking the two drugs as two separate footballs), but the protections against patent-expiry, or generic incursions, seem to be one of the company’s main motivating factors for submitting an ANDA?

I think it likely. Of course, Pharmalot’s Ed Silverman has an even wider, and more cogent, meta-narrative he points us to, this morning — and I think he is largely right. Brilliant, that one (though, Ed, isn’t photocopying US currency, at least theoretically. . . . still a Class B felony? Heh!).

I do think, insofar as meta-narratives go, this is additional proof1 that the pendulum at FDA is swinging toward “slow to approve/quick to issue warning letters” — [as to Schering, then, think about a slower path for its Sugammadex product, even though it holds an FDA “approvable” letter, at the moment — it is not yet “FDA approved“] and thus, relatively-speaking, away from where it had been for a good portion of the two Bush/Cheney administrations.

~~~~~~~~~~~~~~~~~~~~~~~~~

[Footnote 1: I’ll note in passing that FDA drug unit chief Woodcock, and Baxter CEO Bob Parkinson, will appear before a Congressional Committee, at a hearing provocatively-entitled “The Heparin Disaster: Chinese Counterfeits and American Failures“, on this coming Tuesday, to explain how it was that, between FDA inspections of the wrong Chinese supply-plants, and Baxter’s filling and packaging operations (in reliance on various global suppliers, of course) — the batches of Heparin (both the Baxter-versions, and the competitors’ versions) got contaminated, in the first place, shipped into hospitals, in the second place, and injected (or dripped) into the IV lines of patients, in the final analysis. Which is to say, I think it likely that the legislative/investigatory pressures from Sen. Grassley, and Reps. Dingell and Stupak, will not abate — and FDA is adjusting its course, accordingly.]

Probably this wasn’t ever going to "move the needle" very much at Schering, but. . . .

. . . .this is plainly a disappointment for the Fred Hassan/Schering-Plough strategy of taking older, mature-market drugs, and re-igniting them by combining them with another active agent. [Think of Vytorin’s marrying of Zocor with Zetia, here.] While the company said it was “evaluating its response” to the non-approvable letter from FDA, it probably means a[nother] write-off of at least $50 million in development costs, ad pitch consulting and strategy materials, etc. associated with the combo’s one-and-one-half-year journey from FDA submission (August 2007), to last night.

I wonder whether the letter is also a harbinger of things to come at FDA: is this the beginning of a new — more skeptical — FDA review and approval process, when the clinical benefits of these combos appear marginal (as compared to taking the two drugs as two separate footballs), but the protections against patent-expiry, or generic incursions, seem to be one of the company’s main motivating factors for submitting an ANDA?

I think it likely. Of course, Pharmalot’s Ed Silverman has an even wider, and more cogent, meta-narrative he points us to, this morning — and I think he is largely right. Brilliant, that one (though, Ed, isn’t photocopying US currency, at least theoretically. . . . still a Class B felony? Heh!).

I do think, insofar as meta-narratives go, this is additional proof1 that the pendulum at FDA is swinging toward “slow to approve/quick to issue warning letters” — [as to Schering, then, think about a slower path for its Sugammadex product, even though it holds an FDA “approvable” letter, at the moment — it is not yet “FDA approved“] and thus, relatively-speaking, away from where it had been for a good portion of the two Bush/Cheney administrations.

~~~~~~~~~~~~~~~~~~~~~~~~~

[Footnote 1: I’ll note in passing that FDA drug unit chief Woodcock, and Baxter CEO Bob Parkinson, will appear before a Congressional Committee, at a hearing provocatively-entitled “The Heparin Disaster: Chinese Counterfeits and American Failures“, on this coming Tuesday, to explain how it was that, between FDA inspections of the wrong Chinese supply-plants, and Baxter’s filling and packaging operations (in reliance on various global suppliers, of course) — the batches of Heparin (both the Baxter-versions, and the competitors’ versions) got contaminated, in the first place, shipped into hospitals, in the second place, and injected (or dripped) into the IV lines of patients, in the final analysis. Which is to say, I think it likely that the legislative/investigatory pressures from Sen. Grassley, and Reps. Dingell and Stupak, will not abate — and FDA is adjusting its course, accordingly.]

Probably this wasn’t ever going to "move the needle" very much at Schering, but. . . .

. . . .this is plainly a disappointment for the Fred Hassan/Schering-Plough strategy of taking older, mature-market drugs, and re-igniting them by combining them with another active agent. [Think of Vytorin’s marrying of Zocor with Zetia, here.] While the company said it was “evaluating its response” to the non-approvable letter from FDA, it probably means a[nother] write-off of at least $50 million in development costs, ad pitch consulting and strategy materials, etc. associated with the combo’s one-and-one-half-year journey from FDA submission (August 2007), to last night.

I wonder whether the letter is also a harbinger of things to come at FDA: is this the beginning of a new — more skeptical — FDA review and approval process, when the clinical benefits of these combos appear marginal (as compared to taking the two drugs as two separate footballs), but the protections against patent-expiry, or generic incursions, seem to be one of the company’s main motivating factors for submitting an ANDA?

I think it likely. Of course, Pharmalot’s Ed Silverman has an even wider, and more cogent, meta-narrative he points us to, this morning — and I think he is largely right. Brilliant, that one (though, Ed, isn’t photocopying US currency, at least theoretically. . . . still a Class B felony? Heh!).

I do think, insofar as meta-narratives go, this is additional proof1 that the pendulum at FDA is swinging toward “slow to approve/quick to issue warning letters” — [as to Schering, then, think about a slower path for its Sugammadex product, even though it holds an FDA “approvable” letter, at the moment — it is not yet “FDA approved“] and thus, relatively-speaking, away from where it had been for a good portion of the two Bush/Cheney administrations.

~~~~~~~~~~~~~~~~~~~~~~~~~

[Footnote 1: I’ll note in passing that FDA drug unit chief Woodcock, and Baxter CEO Bob Parkinson, will appear before a Congressional Committee, at a hearing provocatively-entitled “The Heparin Disaster: Chinese Counterfeits and American Failures“, on this coming Tuesday, to explain how it was that, between FDA inspections of the wrong Chinese supply-plants, and Baxter’s filling and packaging operations (in reliance on various global suppliers, of course) — the batches of Heparin (both the Baxter-versions, and the competitors’ versions) got contaminated, in the first place, shipped into hospitals, in the second place, and injected (or dripped) into the IV lines of patients, in the final analysis. Which is to say, I think it likely that the legislative/investigatory pressures from Sen. Grassley, and Reps. Dingell and Stupak, will not abate — and FDA is adjusting its course, accordingly.]

Probably this wasn’t ever going to "move the needle" very much at Schering, but. . . .

. . . .this is plainly a disappointment for the Fred Hassan/Schering-Plough strategy of taking older, mature-market drugs, and re-igniting them by combining them with another active agent. [Think of Vytorin’s marrying of Zocor with Zetia, here.] While the company said it was “evaluating its response” to the non-approvable letter from FDA, it probably means a[nother] write-off of at least $50 million in development costs, ad pitch consulting and strategy materials, etc. associated with the combo’s one-and-one-half-year journey from FDA submission (August 2007), to last night.

I wonder whether the letter is also a harbinger of things to come at FDA: is this the beginning of a new — more skeptical — FDA review and approval process, when the clinical benefits of these combos appear marginal (as compared to taking the two drugs as two separate footballs), but the protections against patent-expiry, or generic incursions, seem to be one of the company’s main motivating factors for submitting an ANDA?

I think it likely. Of course, Pharmalot’s Ed Silverman has an even wider, and more cogent, meta-narrative he points us to, this morning — and I think he is largely right. Brilliant, that one (though, Ed, isn’t photocopying US currency, at least theoretically. . . . still a Class B felony? Heh!).

I do think, insofar as meta-narratives go, this is additional proof1 that the pendulum at FDA is swinging toward “slow to approve/quick to issue warning letters” — [as to Schering, then, think about a slower path for its Sugammadex product, even though it holds an FDA “approvable” letter, at the moment — it is not yet “FDA approved“] and thus, relatively-speaking, away from where it had been for a good portion of the two Bush/Cheney administrations.

~~~~~~~~~~~~~~~~~~~~~~~~~

[Footnote 1: I’ll note in passing that FDA drug unit chief Woodcock, and Baxter CEO Bob Parkinson, will appear before a Congressional Committee, at a hearing provocatively-entitled “The Heparin Disaster: Chinese Counterfeits and American Failures“, on this coming Tuesday, to explain how it was that, between FDA inspections of the wrong Chinese supply-plants, and Baxter’s filling and packaging operations (in reliance on various global suppliers, of course) — the batches of Heparin (both the Baxter-versions, and the competitors’ versions) got contaminated, in the first place, shipped into hospitals, in the second place, and injected (or dripped) into the IV lines of patients, in the final analysis. Which is to say, I think it likely that the legislative/investigatory pressures from Sen. Grassley, and Reps. Dingell and Stupak, will not abate — and FDA is adjusting its course, accordingly.]

Probably this wasn’t ever going to "move the needle" very much at Schering, but. . . .

. . . .this is plainly a disappointment for the Fred Hassan/Schering-Plough strategy of taking older, mature-market drugs, and re-igniting them by combining them with another active agent. [Think of Vytorin’s marrying of Zocor with Zetia, here.] While the company said it was “evaluating its response” to the non-approvable letter from FDA, it probably means a[nother] write-off of at least $50 million in development costs, ad pitch consulting and strategy materials, etc. associated with the combo’s one-and-one-half-year journey from FDA submission (August 2007), to last night.

I wonder whether the letter is also a harbinger of things to come at FDA: is this the beginning of a new — more skeptical — FDA review and approval process, when the clinical benefits of these combos appear marginal (as compared to taking the two drugs as two separate footballs), but the protections against patent-expiry, or generic incursions, seem to be one of the company’s main motivating factors for submitting an ANDA?

I think it likely. Of course, Pharmalot’s Ed Silverman has an even wider, and more cogent, meta-narrative he points us to, this morning — and I think he is largely right. Brilliant, that one (though, Ed, isn’t photocopying US currency, at least theoretically. . . . still a Class B felony? Heh!).

I do think, insofar as meta-narratives go, this is additional proof1 that the pendulum at FDA is swinging toward “slow to approve/quick to issue warning letters” — [as to Schering, then, think about a slower path for its Sugammadex product, even though it holds an FDA “approvable” letter, at the moment — it is not yet “FDA approved“] and thus, relatively-speaking, away from where it had been for a good portion of the two Bush/Cheney administrations.

~~~~~~~~~~~~~~~~~~~~~~~~~

[Footnote 1: I’ll note in passing that FDA drug unit chief Woodcock, and Baxter CEO Bob Parkinson, will appear before a Congressional Committee, at a hearing provocatively-entitled “The Heparin Disaster: Chinese Counterfeits and American Failures“, on this coming Tuesday, to explain how it was that, between FDA inspections of the wrong Chinese supply-plants, and Baxter’s filling and packaging operations (in reliance on various global suppliers, of course) — the batches of Heparin (both the Baxter-versions, and the competitors’ versions) got contaminated, in the first place, shipped into hospitals, in the second place, and injected (or dripped) into the IV lines of patients, in the final analysis. Which is to say, I think it likely that the legislative/investigatory pressures from Sen. Grassley, and Reps. Dingell and Stupak, will not abate — and FDA is adjusting its course, accordingly.]

Probably this wasn’t ever going to "move the needle" very much at Schering, but. . . .

. . . .this is plainly a disappointment for the Fred Hassan/Schering-Plough strategy of taking older, mature-market drugs, and re-igniting them by combining them with another active agent. [Think of Vytorin’s marrying of Zocor with Zetia, here.] While the company said it was “evaluating its response” to the non-approvable letter from FDA, it probably means a[nother] write-off of at least $50 million in development costs, ad pitch consulting and strategy materials, etc. associated with the combo’s one-and-one-half-year journey from FDA submission (August 2007), to last night.

I wonder whether the letter is also a harbinger of things to come at FDA: is this the beginning of a new — more skeptical — FDA review and approval process, when the clinical benefits of these combos appear marginal (as compared to taking the two drugs as two separate footballs), but the protections against patent-expiry, or generic incursions, seem to be one of the company’s main motivating factors for submitting an ANDA?

I think it likely. Of course, Pharmalot’s Ed Silverman has an even wider, and more cogent, meta-narrative he points us to, this morning — and I think he is largely right. Brilliant, that one (though, Ed, isn’t photocopying US currency, at least theoretically. . . . still a Class B felony? Heh!).

I do think, insofar as meta-narratives go, this is additional proof1 that the pendulum at FDA is swinging toward “slow to approve/quick to issue warning letters” — [as to Schering, then, think about a slower path for its Sugammadex product, even though it holds an FDA “approvable” letter, at the moment — it is not yet “FDA approved“] and thus, relatively-speaking, away from where it had been for a good portion of the two Bush/Cheney administrations.

~~~~~~~~~~~~~~~~~~~~~~~~~

[Footnote 1: I’ll note in passing that FDA drug unit chief Woodcock, and Baxter CEO Bob Parkinson, will appear before a Congressional Committee, at a hearing provocatively-entitled “The Heparin Disaster: Chinese Counterfeits and American Failures“, on this coming Tuesday, to explain how it was that, between FDA inspections of the wrong Chinese supply-plants, and Baxter’s filling and packaging operations (in reliance on various global suppliers, of course) — the batches of Heparin (both the Baxter-versions, and the competitors’ versions) got contaminated, in the first place, shipped into hospitals, in the second place, and injected (or dripped) into the IV lines of patients, in the final analysis. Which is to say, I think it likely that the legislative/investigatory pressures from Sen. Grassley, and Reps. Dingell and Stupak, will not abate — and FDA is adjusting its course, accordingly.]