Drug approval worth the wait for FDA, pharma

Upton Sinclair's novel The Jungle exposed the unscrupulous practices of the American meat-packing industry and the perils of poisoned and tainted beef from the slaughterhouses of Chicago at the start of the 20th century.

Upton Sinclair's novel The Jungle exposed the unscrupulous practices of the American meat-packing industry and the perils of poisoned and tainted beef from the slaughterhouses of Chicago at the start of the 20th century.

Written nearly a century ago, the book helped fuel national food-safety reforms that have lasted to the present day. Until the recent mad cow scares, the public has been reassured that the Food & Drug Administration has been its watchdog, one immune from industry influence. When we buy beef or other foodstuffs, we have confidence that they will be safe.

The same should be true of drugs. The first rule of medicine is do no harm, but the marketing of cures before their safety and efficacy have been thoroughly evaluated is now putting that promise at risk. It is the FDA's responsibility to ensure that any proposed drug undergoes rigorous, independent, and well-designed scientific review and testing before it is released to the public. On their face, the health dangers of letting culprit companies do what they want should be compelling enough for regulators to take action.

But an additional factor - a serious erosion of public trust - is no less compelling. In evaluating drug safety and efficacy, the public does not know whether to believe the government, the companies, consumer-protection groups, or internet chatter. The credibility of traditionally respected sources of healthcare information is being undermined by modern day snake-oil salesmen, whose ability to sell science is often better than the science itself. The protections printed on labels become lies if the consumer has little faith that such claims are real or that the potential downsides have been carefully analyzed.

In Big Pharma, there often exists a healthy tension between science and marketing. With more ethical companies, the safety of the customer always supersedes market expediency. The first Tylenol product tampering case in 1982 taught us that in the case of Johnson & Johnson, the drug's manufacturer, customer interests came before the interests of shareholders and marketers. J&J used the guiding principles of its founder, Robert Wood Johnson, to do the right thing and not take the path of greed and market share. J&J followed a credo that should be a guiding light for those contemplating a rush to market with drugs that are not ready for prime time.

Clearly, the often-arduous FDA approval process requires a massive investment of time and money in order to weigh safety, efficacy, and therapeutic benefit. Any delays in this process can be onerous for investors anxious to see a return. But investors know the risks when they invest. It is disingenuous to complain about any company that takes the necessary time to get the drug right before it is launched. The pressure to get to market faster must be weighed against the more significant cost to a company's reputation if it gets it wrong and brings drugs to market with safety data that is more gray than the requisite black and white. Safe science must always win out over better marketing if the interests of the public are to be protected. With the aging population and the cost pressures of modern healthcare, there will be an increasing urge to take shortcuts. It is a path to which industry must not succumb. The pharmaceutical industry should be granted patent protection for its long-term investments in research and discovery.

Steps also should be taken to protect firms from the unfair importation of foreign drugs, which also hold potential dangers for an unwary public. The better companies know that their futures are closely tied to how they are perceived in the marketplace, how they deliver on the promise of the miracles of modern medicine, what routes they find to new medicines on the map of the human genome, and whether they can continue to unravel nature's secrets for a long life. When a person is sick, he or she must be able to rely on the words and deeds of all the players in the value chain of medicine, from the diligent scientists and the companies that employ them, to neighborhood pharmacists and primary care physician.

This is the prescription that Hippocrates advised: First, do no harm. And, if trust is to be restored, it is the FDA that must now form our first line of defense.

  • Peter Morrissey is president and CEO of Morrissey & Co.

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