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Big Pharma Is Mellow about FDA Obstacles to Innovation



It sometimes appears that big pharma is comfortable with the hugely expensive FDA drug approval process. Perhaps big pharma firms have learned how to navigate the process and have the resources to do so. And perhaps the process discourages disruptive innovations from small medical startups that have not learned how to navigate the process, and do not have the resources to do so. If so, then the puzzling indifference of big pharma indicated in the passages quoted below, becomes easier to understand.

(There's a wonderful recent TV ad from big pharma supporting innovation by quoting the Dylan Thomas poem saying we should "rage, rage against the dying of the light." If only they really meant it.)



(p. A13) In recent years, the arrival of breakthrough drugs for everything from cancer to rare diseases has led to a surge in the number of patients wanting early access to treatments. The pleas -- sometimes driven by viral social media campaigns -- have proved vexing for companies that have invested millions to get a drug to market and are wary of doing anything to jeopardize their chances.

Today, companies' policies on granting early access to drugs are a confusing patchwork that tends to favor affluent and well-connected patients at leading medical centers, who have the resources and know-how to navigate the system.

"You have to be pretty sophisticated," said Dr. Arthur L. Caplan, a bioethicist at New York University who has been working with companies, including Johnson & Johnson, to develop better early-access programs. But the bill passed this week, he said, "does somewhere between nothing and absolutely nothing to help you."

The bill's passage represented a victory for proponents of "right to try," a campaign championed by Vice President Mike Pence and initiated by the Goldwater Institute, a libertarian think tank that favors limiting the scope of the F.D.A. At least 38 states have passed local versions of right-to-try laws, which allow patients to sidestep F.D.A. approval once they have received permission from a company.

The right-to-try measures are opposed by a broad coalition of groups, which contend the bill will not help patients and will undermine the authority of the primary regulatory agency, the F.D.A. Four former F.D.A. commissioners, including two each from Democratic and Republican administrations, oppose the bills, as do dozens of patient groups, including the American Cancer Society Cancer Action Network and the American Lung Association.

The pharmaceutical industry, while not taking a position on the issue, has been circumspect. A spokesman for its main lobbying group, the Pharmaceutical Research and Manufacturers of America, said on Friday, "We believe any legislation must truly benefit and protect patients and not disrupt the future of clinical trials, U.S. Food and Drug Administration oversight and the research and approval of new medicines."


. . .


The F.D.A. already approves 99 percent of such applications, and the agency has streamlined the approval process. Drug companies also have many other reasons to bar access -- often, companies do not have enough extra product to give to patients, or they worry that the logistical work of granting access could slow efforts to get the drug approved, when it would become available to any patient who needed it.

There is also the possibility that the drug does not work -- many experimental products fail in late-stage trials.


. . .


"In our view, the F.D.A. plays a really important role," Dr. Joanne Waldstreicher, the chief medical officer of Johnson & Johnson, said in an interview Thursday. Johnson & Johnson initiated a program in 2015 that delegates decisions about early access to a program set up by Dr. Caplan. The F.D.A., Dr. Waldstreicher said, has "information that we don't have necessarily; they see safety and efficacy information on products that may be similar."



For the full story, see:

KATIE THOMAS. "For Terminally Ill People, a Convoluted Procedure Just to Give Drugs a Try." The New York Times (Saturday, March 24, 2018): A13.

(Note: ellipses added.)

(Note: the online version of the story has the date March 23, 2018, and has the title "Why Can't Dying Patients Get the Drugs They Want?")






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