A dozen sunscreens sold abroad are more effective than those available here, but U.S. regulators have yet to OK them. A promising new MS drug, Lemtrada, has been in use for years in Europe yet American officials have rejected it. And it can take 15 years for new drugs to go from the lab to the market because of regulatory hurdles they must clear.
These examples beg the question: Are effective new treatments being kept from American consumers because government red tape has tied the hands of Food and Drug Administration regulators?
Joseph V. Gulfo, M.D., a medical entrepreneur and author, tells Newsmax Health the answer is an unqualified yes. In his new book, “Innovation Breakdown: How the FDA and Wall Street Cripple Medical Advances,” Dr. Gulfo argues the FDA has raised the bar so high for new therapies that drug companies and biomedical firms are being stymied in their efforts to bring promising treatments to Americans.
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“The drug development process and for certain types of devices as well … is extremely difficult,” says Dr. Gulfo, in an interview on Newsmax TV’s Meet the Doctors program. “The development process in the pre-clinical phases and all through the clinical phases [is] very very hard. In fact only one in 100 products that make it into the clinic actually get approved.”
He acknowledges that rigorous regulatory standards are necessary to ensure new drugs, products, and medical devices are safe and effective.
“We need to prove drugs are safe and effective,” he says. “And no one in the drug-development world has a problem with that.”
But Dr. Gulfo believes the FDA has gone too far in setting and enforcing the standards that genuine medical advances must meet and clear to move into clinical practice.
“The reason I wrote the book is we’ve now moved from an extremely [difficult] process to a near-impossible process because the FDA … has moved to basically an anti-innovation agenda where the only thing that moves FDA — beyond the slam dunks, beyond the obvious no brainers — is media attention or congressional oversight.”
What’s driving that agenda, Dr. Gulfo argues, is “fear” that the agency may allow an unproven or dangerous product to make its way into the medical marketplace.
“The FDA is afraid,” he maintains. “No one ever got fired for saying no. And that’s the problem. FDA now regulates on a fear-based manner ... there’s an ideology that basically anything new is a potential problem vs. anything new [being considered] a tremendous breakthrough.”
For years, the FDA has been under fire for taking so long to approve new treatments for some of the nation’s big killers. But agency officials have argued that it takes time for appropriate regulatory reviews.
In a recent column for USA Today, FDA Commissioner Margaret Hamburg said the agency places its highest priority on “helping to ensure that patients are protected from potentially harmful drugs or one that doesn’t work.”
But critics point out that, for some terminal patients, such protections are meaningless and there are no other options but to try experimental drugs. Even if some of them prove not to be effective, allowing patients to try them would help advance scientific research and also provide hope to patients.
In recent years, a number of so-called “right-to-try” laws have passed in several states to grant such patients access to experimental drugs — even as the FDA reviews their overall safety and effectiveness.
Colorado enacted such a law in May. In Louisiana and Mississippi, similar measures were passed by state lawmakers. Arizona voters will also have the chance to weigh in on a right-to-try referendum this fall.
In the face of the FDA criticism, the agency says it has improved its approval times for new drugs. Since 2003, the median approval time for a new drug was fallen to 304 days. Under new federal legislation passed in 2102, called the FDA Safety and Innovation Act, the agency has a new Breakthrough Therapy Designation designed to speed approval of new drugs thought to show spectacular promise. Since the law was passed, 44 products have been granted that status and six were approved.
But critics still argue those six were among nearly 180 drug applications. Plus, they note the median approval time for a new drug is still too long at 10 months. What’s more, they say the agency should move more quickly on products that have already met the high regulatory standards set by other nations.
For instance, at least eight new sunscreen ingredients available in products sold in Europe, Asia, and Australia — thought to be more effective than those on the U.S. market — have been pending before the FDA for 10 years, even though skin cancer rates are rising in the U.S. The last over-the-counter sunscreen ingredient was approved by the FDA in the 1990s.
FDA critics claim there doesn’t seem to be much urgency on the part of the FDA to approve these new and better products, even though five times as many Americans are being diagnosed today with skin cancer than in the 1970s — 3.5 million each year, including 70,000 a year with deadly melanoma.
Another example involves the new multiple sclerosis drug, Lemtrada, approved in Europe, Canada, and Australia. In clinical trials, it reduced the relapse rate of MS patients by one-half (versus another drug). It has also already been approved by the FDA for the treatment of chronic lymphocytic leukemia under the name Campath. But still the agency rejected its use for MS patients last December, and requested additional studies of its safety and effectiveness. But the developer of the drug, Sanofi-Genzyme, said it has complied with those FDA requests, yet is still awaiting an FDA decision.
In addition, the Manhattan Institute for Policy Research recently published a report on FDA performance from 2004 through 2012, analyzing the approval times of products from 12 FDA Divisions, and found some are better than others. In fact, two divisions, Oncology and Antivrals, perform much better than the others. The slowest division (Neurology) took 600 days to approve a new therapy, compared to 200 for the two best.
FDA critic say there would be huge gains for patients’ access to new drugs if all the agency’s divisions followed even the example set by the two most efficient FDA divisions.
Citing the FDA’s foot-dragging on Lemtrada and sunscreens, Dr. Gulfo says: “It’s approved in Europe, it’s a great drug [but] FDA won’t approve it and no one understands why. [On sunscreens], there’s over a dozen sunscreens that have been on the market in Europe for more than 10 years and we have one American an hour dying of melanoma and the FDA is not approving these sunscreens.
“There’s just so many things that are still happening that we have to challenge and make better.”
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