Would Washington’s FDA Fix Cure The Patients Or The Drug Industry?

by Alec MacGillis ProPublica, Oct. 20, 2015, 10:04 a.m.

This might seem to be a rough political patch for the pharmaceutical and medical device industries. The exponential price increases of several drugs have brought scrutiny to the overall rise in drug costs and have prompted several 2016 candidates, most notably Hillary Clinton, to vow action to rein in the industry. Meanwhile, thousands of complaints are pouring into the Food and Drug Administration about a contraceptive implant made by Bayer.

In Congress, however, things are looking better for the manufacturers. Legislation is advancing that would speed up the FDA’s approval process for medications and medical devices, offering a rare example of how major initiatives can get traction even in today’s gridlocked Washington.

The industry has mounted a major lobbying and public relations push for the 21st Century Cures Act. The bill, in turn, has garnered an unusually broad range of support, ranging from Republican lawmakers and conservative think tanks to the White House, patient advocacy groups, Democrats and nonprofit organizations that are typically leery of deregulatory efforts by industry. One reason: Lawmakers softened up the usual opponents of looser rules with a big carrot 2014 billions of dollars in new federal medical research funding for the National Institutes of Health. After years of austerity, that money is awfully difficult to turn down.

But the enthusiasts have left a small band of critics warning that bipartisan consensus does not necessarily affirm the bill’s worth. Far from showing that Washington can still get big things done, they say, it shows how a lobby can blow past skeptics if the pot of resources is sweet enough. They maintain that the bill, which easily passed the House in July and has a counterpart soon to be introduced in the Senate, hasn’t received the scrutiny that such sweeping legislation deserves.

“Expanding NIH funding in a substantive amount is a grand and wonderful thing,” said Susan Wood, a former assistant FDA commissioner for women’s health who is now a professor at George Washington University. “But the price of that expansion should not be the gutting of the FDA.”

Wood’s criticism is echoed by other former FDA officials including David Kessler, who was appointed commissioner by President George H.W. Bush, as well as by two Harvard medical school professors who argued in a leading journal that the bill “could lead to the approval of drugs and devices that are less safe or effective than existing criteria would permit.”

For their part, the bill’s proponents say it would spur innovation, particularly when it comes to finding cures for rare diseases2014of the 10,000 or so known diseases, 7,000 are considered rare and treatments exist for only 500. Francis Collins, director of the NIH and a leading champion of the bill, says it now takes “around 14 years and $2 billion or more” to develop a new drug and notes that all but five percent of drugs fail during development.

If the legislation passes the Senate and is signed by President Obama, the FDA would be encouraged to develop faster routes to the approval of new products. Under the current system, most new drugs and devices must pass through multiple levels of clinical trials that can take years to conclude. One alternative would be to make more frequent use of so-called “biomarkers” that gauge physical responses to a drug rather than waiting for the final results from a patient trial.

To increase the incentive for drug makers to seek cures for rare diseases, the bill also would grant an extra period of exclusive marketing rights to a company if an existing drug were approved to treat a rare disease after having been previously approved for a different disease.

“The 21st Century Cures legislation is viewed very positively by both political parties and the public at large,” said Michael Castle, a former House Republican from Delaware who is the vice chairman of Research America, an organization that lobbies for biomedical research funding. “If you get down to a list of substantive legislation that has actually a chance of passage now, something like 21st Century Cures is very high on that list.”

The legislation is responding, in part, to the demand from many patients’ groups for medical breakthroughs. “It doesn’t mean you give the industry free rein, but are you really protecting the public if you’re preventing real cures from getting to them?” said Brian Baird, a former Democratic congressman from Washington state who supports the bill.

The bill’s critics have argued that the FDA has already greatly streamlined its approval processes. A recent analysis by Forbes found that so far this year the FDA has rejected only three never-before marketed drugs, and approved 25, an approval rate of 89 percent, up from 66 percent just seven years ago. “We’re the fastest regulatory agency in the world,” said Gregg Gonsalves, a prominent HIV activist now working as a research scholar at Yale Law School. “Pharma would just be very pleased to do less work for more gain.”

Stephen Ostroff, now the FDA’s interim commissioner, has said the agency initially had concerns about the House bill, but that officials were reassured by revisions. The version that passed would only encourage the agency to use the alternate approval methods, rather than require them. Still, critics note that the FDA would get only $550 million to administer the new approval processes, far less than it says it needs to do so properly.

The legislation has its roots in a longstanding push by conservative groups to liberate drug and device development from red tape. “Now, I don’t want to get your hopes up, but Phase Three, maybe we’ll take out FDA,” said Newt Gingrich during the Republican Revolution of 1994, when he also called the agency the nation’s “leading job killer.” More recently, the deregulatory crusade against the FDA has been led by conservative think tanks such as the Goldwater Institute and Manhattan Institute, which launched its “Project FDA” to reform the agency so that it provides a “more predictable, transparent, and efficient pathway” for new medications and devices.

The cause was taken up in Congress over the last couple years by House Energy and Commerce Committee Chairman Fred Upton, a Michigan Republican who will be giving up his gavel to term limits next year and is, his colleagues say, eager for a major legislative capstone before he leaves. Upton has received major backing from the drug and device industries2014in the last election cycle, they contributed about $370,000 to him and his associated political action committee, according to the Center for Responsive Politics, more than all but two other business sectors.

Besides campaign contributions, the industry has invested in lobbying. The Pharmaceutical Research and Manufacturing Association, which represents drug makers, increased its quarterly lobbying from $3.96 million to $5.44 million as Upton prepared to release the legislation early this year. The Advanced Medical Technology Association, which represents device makers, increased its quarterly lobbying spending from $550,000 to $740,000 in the same period. Drug and device makers themselves also increased their lobbying expenditures, the records show.

But the key for the legislation’s proponents has been to earn support beyond Republicans and the industry.

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