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The Corner

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Don’t Contaminate the Drug-Approval Process



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Members of Congress, working outside the harsh glare of politics, are very close to bipartisan agreement on a bill that would help fund the Food and Drug Administration’s work on drug approval and take much-needed steps toward modernizing the process.

Under the legislation, pharmaceutical, medical-device, and biotech companies would agree to pay at least $6 billion in user fees over the next five years to help fund the FDA’s work on reviewing submissions for safety and efficacy. The user fees provide more than half of the FDA’s budget, and without the fees, the review process would be frozen.

While many hoped for more from the legislation to reauthorize the Prescription Drug User Fee Act (PDUFA), it does include reforms that would allow the FDA to update the drug-approval process with more sophisticated processes and the use of information technologies.

The current PDUFA agreement expires this fall, and committees in the House and Senate already have approved similar bills on a strong bipartisan basis. Senators Tom Harkin (D., Iowa) and Michael Enzi (R., Wyo.) chairman and ranking Republican on the Senate Health, Education, Labor, and Pensions Committee, said in a joint statement that the committee “displayed strong bipartisan cooperation.” They said that in addition to user fees, the bill would help “upgrade FDA’s tools to police the global drug supply chain” and “make medicines safer for millions of children.” Both the House and Senate measures reauthorize legislation to facilitate the development and safe use of prescription drugs for children.

#more#House Energy and Commerce Health Subcommittee Chairman Joe Pitts, (R., Pa.) and ranking member Frank Pallone (D., N.J.) issued a joint statement, also showing the bipartisan spirit: “Reauthorizing and revitalizing the FDA drug and device user fee system is a top priority for members on both sides of the aisle,” the lawmakers said. “This legislation is too important to get wrong, which is why we are working together to protect patients and ensure continuity at the FDA.”

But Senator John McCain is offering an amendment which threatens to gum up the process.

He and several colleagues are concerned about price controls on prescription drugs in other developed countries that artificially inflate prices for U.S. consumers. The McCain amendment to PDUFA would allow drug importation from Canada — basically allowing us to import Canadian price controls.

There is just no way that the FDA could police all of the potential entry points, and there are huge risks that imported drugs would be counterfeit or contaminated and therefore would compromise the whole drug supply in the U.S. That would be a much bigger cost than any savings we might get from drug importation (which seldom actually materialize since the middlemen take a big share of any price differential).

Several states, including Illinois and Minnesota, have allowed citizens to import drugs from Canada to take advantage of our northern neighbor’s price controls on prescription drugs. The plans fizzed.

Canada would simply become a portal for suppliers from any other country to get drugs into the U.S. market. The FDA did an inspection blitz in November 2003 at the Buffalo, Dallas, Chicago, and Seattle mail facilities and the Memphis and Cincinnati courier hubs. The FDA found 1,728 unapproved drugs among the 1,982 parcels inspected. The unapproved drugs included “foreign versions” of FDA-approved drugs, recalled drugs, drugs requiring special storage conditions, drugs requiring close physician monitoring, and drugs containing addictive controlled substances.

We have learned a lot since then about the risks, including the very real threat that terrorists could use these channels to do us harm, and there is just no way that the FDA can police all of the sources where these drugs could enter the country.

This sideshow should not be allowed to sideline PDUFA.

Additionally, consumer activists have complained that the proposed legislation doesn’t include strong enough language to “protect patients from dangerous or defective devices.”

One of the demands of consumer groups is that drug companies conduct “comparative effectiveness” trials to win FDA approval for new medicines. They want companies to demonstrate that their new drugs are proven superior to older medicines to gain marketing approval.

“These requirements would add a major hurdle to the development and approval of new medicines, adding significant time and cost,” according to Scott Gottlieb, a physician, pharmaceutical-industry expert, and scholar with the American Enterprise Institute.

“In situations where differences in the efficacy of two medicines could have important medical implications, the FDA already uses its considerable authority to require head-to-head comparisons between drugs,” according to Gottlieb. “In situations where this sort of comparative data is important to guide cost-effective medical choices, drug companies are doing these trials on their own prerogative to secure insurance coverage and placement on formularies.”

The average cost of bringing a new drug to market in the United States now tops $1.2 billion. The primary effect of adding another layer of bureaucratic hurdles to the drug-approval process will be to further increase the prices of drugs and devices.  

And the consequences of more bureaucracy would be detrimental for patients as well. England requires comparative effectiveness review certification, for example, with its NICE program (National Institute for Health and Clinical Excellence). The result is restricted and delayed access to newer and better drugs and devices, leading to worse health outcomes.

Lancet Oncology, the prestigious medical journal, reports that 84 percent of women in the United States are alive at least five years after receiving a diagnosis of breast cancer. Only 70 percent of British women survive that long. Further, 92 percent of American men with prostate cancer survive for at least five years, compared to 51 percent of Britons.

Congress should proceed with its work in producing unencumbered PDUFA legislation so the FDA can continue to do its work in getting drugs and devices to patients who need them as expeditiously and as safely possible.



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