ICYMI: “Senate Passes F.D.A. Funding and ‘Right-to-Try’ Drug Bills”

“Senate Passes F.D.A. Funding and ‘Right-to-Try’ Drug Bills”
By: Robert Pear and Sheila Kaplan

Click HERE to read the full article online. An excerpt as well as the full story are also pasted below.

Excerpt:

“The food and drug agency depends on user fees to speed the approval of drugs while maintaining strict standards of drug safety.

“‘User fees, where companies fund a portion of the premarket review of their products, account for more than a quarter of all F.D.A. funding, yet the F.D.A.’s authority to collect these fees will expire at the end of next month unless Congress acts. That’s the urgency of getting this bill across the finish line,’ said Senator Susan Collins, Republican of Maine.

“The bill includes a proposal by Ms. Collins intended to prevent huge, unjustified cost increases on decades-old prescription medicines that have no competition. The legislation directs the agency to speed the review of generic drug applications when products on the market have little or no competition.

“As chairwoman of the Senate Aging Committee, Ms. Collins conducted a yearlong investigation that found ‘egregious price spikes for certain off-patent drugs for which there were no generic competitors.’”

Full article:

The Senate on Thursday gave final approval to legislation to finance the Food and Drug Administration, clearing the measure for President Trump and tapping drug manufacturers once again to help pay for the federal review of prescription drugs and medical devices.

The 94-to-1 vote came just hours after the Senate passed a separate bill expanding access to experimental treatments for people with terminal illnesses. This bill, the Right to Try Act, will now go to the House, where more than three dozen lawmakers have endorsed similar legislation.

Mr. Trump is expected to sign the bill reauthorizing user fees to pay for the agency to review medical devices, brand-name drugs, generic drugs and biosimilars, which are copycat versions of costly biologic drugs made from living organisms. The House approved the user fee bill by voice vote on July 12.

The vote capped an often frustrating seven months for Republicans, who hoped to churn out reams of conservative legislation with their control of both chambers and the White House. Since the dramatic failure of the Senate’s health care repeal bill last week, lawmakers have seemed resigned to more incremental successes.

“We’re passing critical legislation. We’re confirming nominees to important positions,” Senator Mitch McConnell of Kentucky, the majority leader, said from the Senate floor on Thursday, citing a series of veterans’ bills and the confirmation this week of a new F.B.I. director, Christopher A. Wray. “We’re taking steps in the right direction.”

Yet, even on their final day in session, lawmakers were reminded of the often uncomfortable marriage between Mr. Trump and the Republican-led Congress. Mr. Trump lashed out over a bill — which he signed grudgingly this week — to sanction Russia for meddling in last year’s presidential election and for its aggression toward its neighbors. The legislation also limits Mr. Trump’s ability to lift or suspend the sanctions himself.

The measure, which the administration sought to block as it moved through the Capitol in recent weeks, is among the most significant accomplishments of this Congress.

Some senators are also maneuvering in response to the White House’s criticisms of Robert S. Mueller III, the special counsel leading the investigation into ties between people in Mr. Trump’s orbit and Russia. On Thursday, Senator Thom Tillis, Republican of North Carolina, and Senator Chris Coons, Democrat of Delaware, introduced legislation that would allow for judicial review if a special counsel was removed.

The F.D.A. bill, which passed overwhelmingly in both houses, was a struggle, taking lawmakers more than a year to forge a consensus among Republicans, Democrats, F.D.A. officials and drug and device companies.

“This is a bill that’s been done the right way,” said Senator Lamar Alexander of Tennessee, the chairman of the Senate health committee, in a subtle dig at Republican leaders who bypassed the committee and Democrats on their failed push to repeal the Affordable Care Act. “It’s an example of the way the Senate is supposed to work.”

Senator Patty Murray of Washington, the senior Democrat on the committee, said, “This is really a great example of how Congress can actually work together on health issues and solve challenges.”

The food and drug agency depends on user fees to speed the approval of drugs while maintaining strict standards of drug safety.

“User fees, where companies fund a portion of the premarket review of their products, account for more than a quarter of all F.D.A. funding, yet the F.D.A.’s authority to collect these fees will expire at the end of next month unless Congress acts. That’s the urgency of getting this bill across the finish line,” said Senator Susan Collins, Republican of Maine.

The bill includes a proposal by Ms. Collins intended to prevent huge, unjustified cost increases on decades-old prescription medicines that have no competition. The legislation directs the agency to speed the review of generic drug applications when products on the market have little or no competition.

As chairwoman of the Senate Aging Committee, Ms. Collins conducted a yearlong investigation that found “egregious price spikes for certain off-patent drugs for which there were no generic competitors.”

The “right-to-try bill,” introduced by Senator Ron Johnson, Republican of Wisconsin, aims to establish a new pathway for terminally ill patients to gain access to experimental drugs that have not been approved by the F.D.A. These patients are often extremely ill and unable to participate in clinical trials, or have no other treatment options.

Under current law, drug companies can already provide access to patients outside of clinical trials under a program known as expanded access or compassionate use. The F.D.A. already approves about 99 percent of compassionate use requests.

But companies sometimes refuse, fearing that the results could be used against them by the F.D.A. In some cases, drug makers fear they could be sued by patients who say they have been injured by unapproved drug products.

The bill would establish national standards and rules to help channel drugs still under development to terminally ill patients. It also would shield pharmaceutical companies and doctors from some of the legal risks of providing drugs that have not been approved by the agency. Companies that manufacture such drugs and doctors who prescribe them would generally be protected unless they engaged in “reckless or willful misconduct” or “gross negligence,” or intentionally harmed a patient.

“These are real people facing their mortality with no hope,” Mr. Johnson said. “This right-to-try piece of legislation will give those individuals and families hope.”

Lawmakers and right-to-try advocates often say that terminally ill patients have nothing to lose. But those who oppose the bill say there is a difference between dying comfortably and dying horribly, suffering pain and other side effects of an unapproved drug.

Patients seeking access to unapproved drugs often contact members of Congress and their aides, who in most cases do not have the medical background to determine whether a treatment is safe and effective.