A Win for Patients

This article is from the archive of The New York Sun before the launch of its new website in 2022. The Sun has neither altered nor updated such articles but will seek to correct any errors, mis-categorizations or other problems introduced during transfer.

The New York Sun
The New York Sun
NEW YORK SUN CONTRIBUTOR

It isn’t often that the U.S. Senate passes legislation that is both in the public interest and resists the temptation to engage in harmful populist grandstanding. But that is what the Senate did Wednesday when it passed the Food and Drug Administration Revitalization Act. The senators voted, 49 to 40, to effectively torpedo an effort by Senators Dorgan and Collins to allow the importation of price-controlled drugs from Canada.

That’s a win for patients. A free market is one of the conditions that allows the American pharmaceutical industry, in which New York has such a stake, to remain the world’s most innovative and productive. The presence of price controls in Europe, by contrast, is what has turned the once cutting-edge European industry into a shadow. Opening the borders to “Canadian” drugs would risk opening the floodgates to the rising tide of counterfeit pharmaceuticals worldwide.

One would think, given the importance the New York pharmaceutical industry attaches to this legislation, that Senators Schumer and Clinton might have opposed the Canadian scheme. But they both voted against an amendment offered by Senator Cochran, undercutting the Canadian scheme by requiring that the federal government certify the safety of drugs from Canada. That’s a vote in favor of the Canadian dodge, a policy that would be damaging to New York-based pharmaceutical companies Pfizer and Bristol-Myers Squibb. Senator Lieberman, who is of Connecticut, where Pfizer also is a major presence, voted for the Cochran amendment.

The Senate bill also renews the Prescription Drug User Fee Act of 1992, which allows drug makers to pay about $400 million in user fees to the Food and Drug Administration to hire staff needed to win approvals for new treatments. PDUFA has helped slash the average review time and the number of drugs approved has increased significantly. Naturally, the Naderite left has long opposed PDUFA.

But there is no evidence that the FDA has been shy about cracking down on potentially unsafe medications in the PDUFA era. In 1997, for instance, weight-loss drug Fen-phen was recalled because it was linked to heart-valve deterioration and pulmonary hypertension. Also, Bayer’s cholesterol-fighting statin Baycol was recalled in 2001 when cases of fatal rhabdomyolysis were reported in association with its use significantly more frequently than with comparable treatments.

The thing to remember in all this is that when it comes to innovative medicines, safety is rarely an “either/or” question, as Peter Pitts, a former FDA associate commissioner and president of the market-oriented Center for Medicine in the Public Interest, pointed out recently in the Journal of Life Sciences. On a net basis, people are living longer and healthier than ever before, thanks in good part to the availability of remarkable new drugs. Keeping the innovations coming will only become more critical now that the first baby boomers are senior citizens. The Senate has demonstrated a willingness to do that, no help from our own senators.

The New York Sun
NEW YORK SUN CONTRIBUTOR

This article is from the archive of The New York Sun before the launch of its new website in 2022. The Sun has neither altered nor updated such articles but will seek to correct any errors, mis-categorizations or other problems introduced during transfer.


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