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Expedited Drug Approval Pathways Could Compromise Safety

Apr 11, 2017

Biotech companies have hailed the U.S. Food and Drug Administration's recent speeding up of the drug approval process.

Drug makers, which have massive investments in developing new medicines, are eager for their new drugs to start generating revenue and they welcome faster decisions. But critics say the FDA's faster process may imperil patient safety, the Boston Globe reports.

The FDA faces pressure not only from the drug industry and its investors, but also from the Trump administration, which wants to reduce regulations.

The attorneys at Parker Waichman understand the drug approval process and can address patient concerns about the drugs prescribed for them.

Speeded-up FDA Approvals

Expedited Drug Approval Pathways Could Compromise Safety

In March, the FDA gave early approval to cancer drugs from EMD Serono of Rockland, Massachusetts and Tesaro Inc. of Waltham, Massachusetts, as well as an eczema treatment from Sanofi Genzyme (Cambridge). In late December, regulators approved Biogen's Spinraza (nusinersen), a drug to treat spinal muscular atrophy. Biogen had earlier been told to expect the decision in May 2017.

Expediting reviews of new drugs has long been a goal of the FDA itself. After a White House meeting with drug company executives, President Trump called the FDA's approval process "slow and burdensome," according to the Globe. He promised to take action to bring promising new drugs to market more quickly. Scott Gottlieb, Trump's nominee for FDA commissioner, shares Trump's complaints about the approval process. Gottlieb has "strong ties" to the biopharmaceutical business, the Globe reports.

But critics of the push to shorten the approval process, including Dr. Michael Carome, who directs the health research group at Public Citizen, say the pendulum has swung too far toward speedy approvals and away from making sure new drugs are safe and effective. Carome said the approval process is "already too fast," and could not be made any faster "without compromising public health."

Gottlieb, in confirmation hearings before the Senate, pledged to maintain the FDA's "gold standard" of unbiased and science-based drug reviews. "We should reject a false dichotomy that it all boils down to a choice between speed and safety," Gottlieb said.

Dr. Aaron S. Kesselheim, who directs the Program on Regulation, Therapeutics, and Law at Brigham and Women's Hospital in Boston, said the medical community will need to closely monitor Gottlieb and the FDA in light of the new climate of deregulation. Kesselheim said the FDA's drug review times are the fastest they have ever been. More than two-thirds of new drug applications are given some kind of expedited review. Kesselheim said there is no evidence of an FDA bottleneck. He describes administration officials as "ideologically driven" and nonscientific. "Patients want drugs that work," Kesselheim said. "To reduce the FDA's role in the name of free-market deregulation is wrongheaded."

The New England Journal of Medicine recently reported that in recent years the FDA has approved more drugs than European regulators, and has done so two to three months faster, on average.

The drugs approved last month from EMD Serono, Tesaro, and Sanofi Genzyme were all reviewed under at least one of the FDA's expedited programs designed to bring products to market quickly, according to FDA spokeswoman Sandy Walsh. But Walsh noted that every drug approved for sale in the U.S. must demonstrate "meaningful results" for patients in clinical trials.

Under the Prescription Drug User Fee Act of 1992, the FDA committed itself to completing standard drug reviews in 10 months and said that it would make "priority" reviews - for drugs offering a treatment where none exists - within six months. Fast-track approval and breakthrough therapy designation speed up the process.

But accelerated approvals have been controversial. Drug makers are sometimes allowed to use clinical trials that focus on "surrogate endpoints"-changes in laboratory test measures that are not felt by patients - rather than tangible benefits, such as reducing symptoms, keeping patients out of the hospital, and helping them to live longer.

Speeded-up FDA Approvals

In addition to concerns about the speed of the approval process, critics question whether the FDA has been letting drugs reach the market with insufficient evidence of effectiveness. A recent example is drug approved last year for Duchenne muscular dystrophy, a muscle-wasting disease. FDA staffers were divided over the effectiveness of the drug; some said tests on a small number of patients did not prove a clinically meaningful benefit. But the drug was ultimately approved, after lobbying by patient advocates. Because there is currently no other drug available for Duchenne, advocates-many of them parents of children with the disease-wanted this drug to be available, even if it might not be effective for more than a small number of children with the disease. Duchenne muscular dystrophy affects an estimated one in 3,500 male children worldwide. Duchenne is severe progressive disorder that destroys muscles beginning in childhood. It frequently leads to death by the age of 30. An estimated 15,000 Americans are affected by the disease.

The president and others have advocated allowing new drugs to come to market if they have been shown to be safe, even if their effectiveness has not been determined. But critics say effectiveness is an important consideration. Patients may waste precious time taking a drug that is not effective when there may be older treatments that have benefits. A further concern is that many patients assume a newer drug must be better than an older one and they press their doctor to prescribe the newer medicine. Doctors worry that drug company hype about new medicines may create unwarranted preferences for new drugs.

Help for Those Concerned about New Drugs

If you believe you have been harmed by a new drug that may have been rushed to market without adequate testing, or if you have concerns about the safety of the approval process, contact Parker Waichman LLP for a consultation about your option. The firm can offer a free, no obligation case evaluation. To reach the firm, fill out the contact form or call 1-800-YOURLAWYER (1-800-968-7529).


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