ReputationRx

The Food and Drug Administration's image woes do not bode well for the healthcare industry

The Food and Drug Administration's image woes do not bode well for the healthcare industry

For the public to trust the drugs they take - and, in turn, trust drug companies - they need to believe that the regulators who approve those products act in their best interest.

The healthcare industry has long argued that high drug prices are directly influenced by research and development costs; that for every drug approved by the FDA, others never make it through clinical trials.

For sure, bringing drugs to market is a gamble. Profits from blockbusters fund not only the cost of that drug, but also every failed compound. Drug approval in the US is widely considered to be the most stringent process worldwide. In short, Americans pay a premium for the assurance that medication is safe.

But that message has recently become muddled.

Even before the Vioxx recall - but certainly accelerated by it - the current story in the media has been that the FDA is hand in pocket with the drug industry.

The FDA has been plagued not only by the Vioxx debacle, but also charges that it withheld information about the suicide risk for teenagers taking antidepressants.

The story is now this: Drug companies pressure the FDA to approve their products. They then spend hundreds of millions of dollars touting benefits and downplaying risks. People are swayed. They take these drugs, and are horribly damaged.

The drug companies meanwhile - or so the story goes - are laughing all the way to the bank.

To counter the criticism, the FDA has wisely vowed to throw open the doors of communication - in a sense, undertake its own direct-to-consumer PR effort.

But it must clean house first. Some of the harshest criticism toward the FDA has come from whistleblowers inside the agency. The FDA must shake internal and external criticism - warranted or not - that it cares more about profits than patients.

The public cannot trust an agency that does not trust itself.

It's a noble mission - one that the healthcare industry should wholly support. But it's a mission that will have its martyrs.

After all, for the FDA to repair its own name, it will need to distance itself from the primary target of criticism: the much maligned drug industry. Signs are there it intends to do just that, as industry veterans already predict that the FDA will come down harder on pharmaceutical companies.

The agency must demonstrate that it has raised the bar on safety standards. To do so will require the FDA to demand more safety data on compounds still being tested as well as ones already on pharmacy shelves.

Disclosure - almost a buzzword these days - will also take on greater importance as the medical community lobbies for a public registry of clinical trials.

But despite the initial roadblocks, the healthcare industry will emerge stronger from the reforms. The FDA is the coveted third party endorser, the ultimate influencer. But its seal of approval must mean something to the public.

In the end, the credibility of the FDA is worth much more than the cost of additional studies. It's the only way the public will see drug costs as an investment, not a punishment.

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