Friday, October 06, 2017

Congress Could Let All Patients Have the 'Right to Try' Without Going Through the FDA's Complicated Application Process

It is a rare thing to see Congress pass a law that increases personal freedom.

Yet that is exactly what it could do later this fall if the House follows the Senate's lead on a so-called "Right to Try" bill. The law would allow individuals with terminal illnesses, without having to first get permission from the Food and Drug Administration, to try drugs that have not been approved. Since 2012, 37 states have adopted "right to try" laws, giving patients to access experimental treatments that have cleared the first phase of the FDA's trials, with the permission of a doctor.

Passing a law at the federal level would be important for residents of those remaining 13 states, but would also help steer FDA policy, advocates say.

"Right to try is about the terminal patients who don't fit into a control group, who can't afford to travel or move to another country, and who simply want permission to seek the same treatments that other patients—sometimes patients in the same medical facility—are already receiving," says Naomi Lopez Bauman, director of healthcare policy for the Goldwater Institute, an Arizona-based free market think tank that has largely spearheaded the state-level Right to Try movement.

The U.S. Senate in August passed—by unanimous consent—Senate Bill 204, a right to try bill sponsored by Sen. Ron Johnson, R-Wis. That bill, and a similar proposal sponsored by Rep. Morgan Griffith, R-Va., were the subject of a hearing hosted Tuesday by the House Committee on Energy and Commerce. There is no immediate timetable for either bill to receive a vote on the House floor, and Tuesday's hearing made clear that right to try legislation faces more opposition in the lower chamber than it did in the Senate.

"The legislation being proposed could expose critically ill patients to greater harm," worries Rep. Frank Pallone, D-N.J., minority chairman of the committee. Other Democrats expressed similar worries, even while expressing sympathy for patients who are asking little more than for government to get out of the way during the final days of their lives. There are "very legitimate frustrations with the current system," for allowing patients access ot non-FDA-approved drugs, admitted Rep. Gene Green, D-Texas. But those problems are not a good reason to remove the FDA from the process, Green said.

Currently, the FDA runs a so-called "expanded access" program for terminally ill patients who cannot get into drug trials for various reasons. According to a Government Accountability Office report published in July, FDA had approved 99 percent of the 5,800 requests made from 2012 through 2015 by patients seeking access to the program.

Lack of access, then, is not the problem, but time is. Patients with terminal illnesses can wait as little as a few hours to as long as 30 days for the FDA to respond to a request to try a new drug, according to the GAO, and that wait could ending any slim hope of finding a successful treatment. If you think dealing with bureaucrats is awful when you're standing in line at the DMV or applying for a passport, imagine having to go through that same process when your life is on the line.

Under Scott Gottlieb, the newly appointed commissioner of the FDA, the administration has moved to slash the amount of paperwork necessary to get patients enrolled in expanded access programs. Earlier Tuesday, Gottlieb announced further reforms to streamline the experimental treatment review process for patients and doctors. The FDA "believes difficult decisions about individual treatment are best made by patients with the support and guidance of their treating physicians," Gottlieb told the committee Tuesday.

Those welcome changes do not accomplish as much as a federal right to try law, in part because the FDA's statistics are something of an illusion. Gottlieb says the FDA accepts 99 percent of all applicants, ignoring how many patients don't bother going through the process in the first place.

About 500,000 Americans die of cancer each year, but the FDA receives only 1,200 applications from all terminally ill patients for its expanded access programs. The gap suggests a large number of patients who aren't asking for access to experimental drugs because they either don't know about the FDA's programs or don't care to navigate the system.

If nothing else, the recent groundswell of support for state-level right to try laws suggests the status quo isn't working for many patients.

Advocates for right to try also point out that the FDA has only gotten its act together because of pressure applied by the widespread adoption of right to try laws in the states. It wasn't until last year that the FDA announced it was creating a web portal to help guide patients through the expanded access application process. The website is only now being rolled out for public use.

"Shorter forms and hand-holding bureaucrats don't fix the system's fundamental flaw," Christina Sandefur, vice president of the Goldwater Institute, told Reason via email in response to Gottlieb's comments Tuesday. "It requires dying patients who have exhausted all government-approved options to beg the government for permission to obtain treatment to save their lives."



Abusive gerrymandering can be stopped, but not by judges

Jeff Jacoby

Two of the oldest traditions in US political history are at the heart of Gill v. Whitford, a case now before the Supreme Court.

One of those traditions is gerrymandering — the mapping of legislative districts so that they become one-party monopolies. The other tradition is condemning such mapmaking as a cancer on American democracy.

Lawmakers have been manipulating election maps to their political advantage from the Republic's earliest days. When Elbridge Gerry (signer of the Declaration of Independence, delegate to the Constitutional Convention) was governor of Massachusetts in 1812, his allies drew the state's congressional lines to favor their party, the Republican-Democrats, stacking the deck against the opposition Federalists. Infuriated Federalists blasted the map's ungainly new districts, especially one in Essex County that resembled a salamander. A cartoonist drew it with wings and claws, and the "gerry-mander" was born.

Both parties engage in gerrymandering when it suits their interests; both parties denounce gerrymandering when it thwarts those interests. In 1987, President Ronald Reagan inveighed against the partisan cartography of California Democrats, who had "so rigged the electoral process that the will of the people cannot be heard." In the latest election, Reagan complained, Republican candidates had gotten most of the votes, yet Democrats won most of the seats.

The identical complaint, with the parties reversed, is at play in the current case. After the 2010 Census, the GOP majority in Wisconsin's legislature gerrymandered state assembly districts so effectively that, in the 2012 elections, Republicans won 60 percent of the seats despite drawing only 48.6 percent of the votes.

There is agreement across the board that gerrymandering is a bipartisan sin, one that has only grown worse with modern computer-aided algorithms and mapping software. The damage gerrymandering does to democratic accountability — to the people's right to choose their representatives — is widely resented. Polls consistently show that majorities of voters think legislative maps drawn by legislators are unfair.

Partisan gerrymanders are a large part of the reason contemporary politics have grown so toxic. As Senators John McCain and Sheldon Whitehouse argue in a friend-of-the-court brief, the proliferation of ultrasafe legislative seats has led "to a more polarized and dysfunctional political climate. In safe districts, an incumbent's biggest threat is often a primary challenge from a more extreme member of his or her own party. This threat makes legislators reluctant to work across the aisle and support bipartisan legislation."

Thanks to hyperpartisan redistricting, competitive elections for the House of Representatives have largely disappeared. About 90 percent of incumbents are routinely reelected. The average margin of victory is around 65 percent. Gerrymandering has made a sham of most congressional elections. Whatever else the House of Representatives is, it isn't representative.

The malady is easy to diagnose. The remedy is a different matter.

The plaintiffs in Gill are asking the Supreme Court to declare overly partisan redistricting unconstitutional, on the grounds that it deprives voters of the equal protection guaranteed by the 14th Amendment. Heretofore, the court has resisted such pleas, considering it improper for the judiciary to insert itself into partisan skirmishing. In Justice Felix Frankfurter's formulation, "Courts ought not to enter this political thicket." That is still sound advice.

Yes, redistricting is noxious. Yes, it makes American politics worse. But not every problem is one that courts can solve. The Constitution explicitly, and wisely, leaves the details of organizing congressional elections to the political branches: "The Times, Places, and Manner of holding Elections for Senators and Representatives, shall be prescribed in each State by the Legislature thereof; but the Congress may at any time by Law make or alter such Regulations."

Political gerrymandering should be replaced with a fairer system. But it's up to the states and Congress, not judges, to make that happen. Judicial confirmation battles are already bruising and unpleasant. Imagine how much uglier they will become if judges become the arbiters of whether political maps are too, er, political.

The best alternative to gerrymandering is to take redistricting away from politicians and entrust it to an independent commission. It isn't an impossible dream: Three states (California, Arizona, and Iowa) already use such commissions. If voters elsewhere really object to gerrymandering — not just when pollsters ask about it — they have the power to force change. Let the pressure for reform grow sufficiently acute and abusive mapmaking will be curtailed. But that pressure has to come from below. This is a political ill, to be healed by political means.



A Tale of Two Budgets

This week, the House is voting on a Fiscal Year 2018 budget while at the same time the Senate is debating its own version – and there are a number of stark differences. The following is a statement from Maya MacGuineas, president of the Committee for a Responsible Federal Budget:

For all the years of GOP lawmakers calling for balanced budgets, at least on paper, the House budget would reach balance, while the Senate budget would not.

The House also expedites an important down payment on deficit reduction by calling for over $200 billion in spending cuts from reconciliation. That’s not enough, but far more than the Senate’s minimum target of $1 billion in savings. Yes, one.

The House budget also expedites tax reform that does not add to the debt – the clearly stated past goal of the President's budget, Republican leaders, and the White House – while the Senate budget allows for $1.5 trillion in additional borrowing. (Just to restate that, the Senate would allow $1.5 trillion in tax cuts and asks for only $1 billion in spending cuts.)

Both budgets rely on vastly overstated economic growth numbers, but the Senate budget includes those assumptions in a way that will actually make the debt worse.

No independent economist or forecaster anywhere is predicting the kind of sustained economic growth that would be necessary for tax cuts to be self-financing, and Congressional leaders should not be banking on it as policy. In fact, tax cuts that add to the debt will suppress economic growth, not unleash it.

If the current Senate GOP budget – or anything close to it – becomes our fiscal roadmap, no person supporting it will be able to claim to be a fiscal conservative or supporter of fiscal responsibility.

The House budget, on the other hand, paves the way for more responsible, revenue-neutral tax reform accompanied by at least some mandatory spending reductions that are a down payment on fiscal responsibility.

If lawmakers are unwilling to pass a budget that would truly put our debt on a downward path and address both tax and major entitlement reform, Members of Congress should at least reject adding trillions to the national debt on massively exaggerated promises of economic growth and take an approach that more closely resembles the House budget.

Media release from Committee for a Responsible Federal Budget (


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