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Archive

Category: FDA

Politics Vs. Science = White House Vs. The FDA?
By Ed Silverman
Pharmalot
April 02, 2012


barack-obama

Last winter, the Obama administration took the unprecedented step to overrule the FDA, which was about to grant easier access to girls 16 years old and younger to the Plan B pill, which is also known as the morning after pill. The move caused a firestorm of controversy in which the White House was accused of pandering to conservatives during an election year (back story).

But, of course, this is not the only episode that has pitted the Obama administration, which is always struggling to contain criticism about overreaching regulations, against the FDA, which oversees so many products used by so many Americans. There have also been less-publicized clashes about movie popcorn and sunscreen, as The New York Times writes in an insightful piece.

However, the spat about a new law requiring many eateries, including movie theaters, to post calorie counts typified political concerns that have guided the White House in its dealings with the agency. In this instance, the Times writes, the FDA was forced to reverse its draft guidance. “This was the era of Glenn Beck, and the White House was terrified that Beck would get up and say this is all part of the nanny state,” an unnamed senior FDA official tells the paper.

Of course, this is can cause a problem for the FDA, which is already under attack by many Republicans and patient advocacy groups, as well drug and device makers, for not approving products faster. The White House efforts to thwart FDA efforts to issue various regulations or endorse certain products threatens to undermine agency legitimacy and harm standards.

“In a globalizing world, where trust is a huge part of what American manufacturers have to sell, the politicization of the FDA could hurt not only consumer protection but industry profits as well,” Daniel Carpenter, an FDA historian at Harvard University, tells the paper. “If this trend continues, one could easily see major government purchasing programs in Europe, India, China and elsewhere saying, ‘We’re not going to follow FDA recommendations anymore.’ ”

And here is another example of White House intrusion. Do you remember Makena? Last year, the FDA approved this drug to prevent premature births under the Orphan Drug Act. For decades, compounding pharmacies regularly sold for $10 to $10 an injection for a 20-week treatment. But KV Pharmaceutical immediately charged $1,500 a week, since the drugmaker had a lock on the market (back story).

As the Times notes, the FDA would normally have banned the sale of older, unapproved drugs. And KV Pharmaceutical, not surprisingly, was already pushing in that direction itself by sending letters to compounders threatening legal action. However, the FDA unexpectedly announced that it would not pursue any “enforcement actions” against compounders unless there were safety problems (see this).

Why? The Obama adminstration was concerned about the searing publicity over Makena pricing since a federal agency had allowed a monopoly to develop (read thisthis and this). And so the FDA was instructed to issue its statement, the Times writes, adding that the Medicaid director at the Centers for Medicare and Medicaid Services sent a memo to state Medicaid programs that they could continue buying cheaper compounded versions.

This was a significant development because the FDA was dragged into a debate over cost.

One other example of White House intrusion was cited. This involved a spat about the Primatene Mist asthma med and whether to remove the drug because it contained chlorofluorocarbons or CFCs, which can deplete the ozone layer and were banned by an international treaty. The FDA had warned Amphastar Pharmaceuticals about the looming ban, but the drugmaker never created a follow up without CFCs.

A lobbying effort ensued involving several senators, the Times writes, but there was also an effort by Cass Sunstein, who heads the Office of Information and Regulatory Affairs at the White House. His voice counts because his office must approve new rules, although the law governing the ban was already in place, so the FDA did not need his agreement and resisted his moves, the Times writes.

As an aside, Sunstein also surfaced last year in connection with an effort to gut portions of a new National Institutes of Health rule governing disclosure of conflicts of interest. A probe was undertaken by US Senator Chuck Grassley as a result (back story).

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