Judge sides with teen on boys’ restroom issue
A federal judge in Virginia sided Tuesday with a transgender teenager who spent most of his high school years fighting to use the boys’ bathroom in a case that stood at the center of the national fight for transgender student rights.
The judge said the school board that passed bathroom restrictions violated the teen’s constitutional rights.
Gavin Grimm, 19, sued the Gloucester County School Board after it passed a policy requiring students to use bathrooms that aligned with their “biological gender.” Grimm, who was assigned the gender female at birth, told his classmates he was transgender his sophomore year and began using the boys’ bathroom. When parents learned of it, they protested to the school board, which passed the restrictions.
The decision comes as schools, lawmakers and courts wrestle with how to accommodate students whose gender identity conflicts with the sex on their birth certificate.
Grimm argued the restriction violated Title IX, which prohibits sex discrimination in schools that receive federal funds. The Obama administration backed him, filing briefs supporting his case. But a federal judge in 2015 denied the teen’s request for a court order so he could use the boys’ bathroom.
The U.S. Court of Appeals for the 4th Circuit ruled in Grimm’s favor, deferring to the Obama administration’s argument that bathroom restrictions for transgender students violated Title IX. Soon after, the Education Department issued guidance directing all public schools to allow students to use bathrooms in accordance with their gender identity, even when it conflicted with the sex on their birth certificate.
Grimm’s case was appealed to the Supreme Court by the school board, and the court was set to hear it in spring 2017.
The move infuriated conservatives and several states sued to overturn the Education Department guidance. After President Donald Trump took office, Education Secretary Betsy DeVos and Attorney General Jeff Sessions rescinded the guidance.
The Supreme Court sent Grimm’s case back to a lower federal court after the Trump administration reversed the guidance on transgender student rights.
Congress gave final approval Tuesday to a bill that would allow patients with serious illnesses to try unproven experimental treatments, sending the measure to President Donald Trump, a strong supporter of the legislation.
By a vote of 250-169, the House passed the same “right to try” bill that was approved in August by unanimous consent in the Senate.
The bill would, in effect, allow dying patients to bypass the Food and Drug Administration and obtain an “investigational drug” with the approval of their doctors, if the drug manufacturer agrees to supply it.
On at least three occasions in the past four months, Trump has urged Congress to pass the bill.
“Patients with terminal conditions, and terminal illness, should have access to experimental treatment immediately” and “should not have to go from country to country to seek a cure,” he said in January in his State of the Union address.
In a Twitter post Tuesday, Dr. Scott Gottlieb, the commissioner of the FDA, said, “When the House passes #RightToTry legislation I stand ready to implement it in a way that achieves Congress’ intent to promote access and protect patients.”
The chief sponsor of the bill, Sen. Ron Johnson, R-Wis., said that it “expands the scope of individual liberty” and provides “hope for terminally ill patients who have nowhere else to turn.”
Critics said the bill was not as innocuous as it sounded. It was opposed by many Democrats and by dozens of organizations that represent patients, including the National Organization for Rare Disorders and the lobbying arm of the American Cancer Society.
The right-to-try bill “could greatly increase the likelihood of our patients being harmed by unsafe and ineffective experimental therapies,” the health groups said in a letter to House leaders.
“We are deeply saddened,” said Ellen V. Sigal, the chairwoman of Friends of Cancer Research, an advocacy group. “This bill endangers patients and will offer them no value, just false hope.”
The main lobbies for the drug industry, the Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization, said they had not taken a position on the bill.
Under the bill, a patient is eligible to receive an unapproved drug if he or she has “a life-threatening disease or condition” and has “exhausted approved treatment options and is unable to participate in a clinical trial” of the drug. Sponsors of the bill said it could help people with cancer, muscular dystrophy and Lou Gehrig’s disease, also known as amyotrophic lateral sclerosis, among other conditions.
“Why do you not want to allow these patients to exercise their right to fight for their future?” Rep. Michael C. Burgess, R-Texas, asked opponents on the House floor.
Twenty-two Democrats joined 228 Republicans in voting for the bill. All of the no votes were cast by Democrats.
Patients will have to provide informed consent in writing before obtaining an unapproved drug under the bill. Manufacturers will have to provide the government with an annual summary of use of the drug, including “any known serious adverse events.”
Nothing in the bill requires pharmaceutical companies to provide experimental drugs to patients who request them. Drugmakers sometimes turn down requests because they have only a limited supply or because they are concerned about legal and medical risks.
To address such concerns, the legislation would shield drug companies, doctors and hospitals from some of the legal risks of providing unapproved drugs to patients. Doctors and hospitals would generally be protected unless they engaged in “reckless or willful misconduct” or “gross negligence,” or intentionally harmed a patient.
The House passed a similar bill with more protections for patients in March, but the Senate never took it up. So the House decided on Tuesday to pass the Senate bill.
Several former commissioners of the FDA and some clinical experts at the agency said the bill was unnecessary because patients with a serious illness could already obtain experimental medicines through a program known as expanded access or compassionate use.
The agency says it approves 99 percent of the requests it receives under this program, but in some cases, it recommends changes to protect patients before allowing the treatment to proceed.
Burgess said consumers had gained access in recent years to many innovative treatments. But, he said, “We continue to hear from patients with serious life-threatening conditions who remain frustrated with what they see as regulatory barriers to trying new therapies when everything else has failed them.”
Rep. Frank Pallone Jr. of New Jersey, the senior Democrat on the Energy and Commerce Committee, said that reputable drug companies would not provide drugs to patients without the blessing of the FDA. But, he said, the bill opens the door for “a bad actor, some unscrupulous manufacturer, a fly-bynight outfit to promote something like snake oil, whether the FDA approves it or not.”
Pallone said the bill’s definition of a life-threatening disease could be stretched to allow access to experimental drugs for people with manageable conditions, like severe diabetes or chronic heart failure.
Scientists would need to complete the first phase of clinical research on a drug before it could be made available under the bill.