A U.S. pharmaceutical executive is defending his price boost of a key antibiotic by 400 percent to almost $2,400 a bottle as a “moral requirement,” a claim that drew an immediate rebuke from the country’s drug regulatory chief.

Nostrum Pharmaceuticals president Nirmal Mulye told The Financial Times he had a “moral requirement to sell the product at the highest price,” pushing the price of the antibiotic mixture called nitrofurantoin from $474.75 to $2,392 a bottle. The World Health Organization calls the drug an “essential” medicine for lower urinary tract infections.

Mulye told the newspaper, “I think it is a moral requirement to make money when you can. This is a capitalist economy and if you can’t make money you can’t stay in business.”

He compared his decision to increase the price to that of an art dealer selling “a painting for half a billion dollars” and said he was in “this business to make money.”

The Food and Drug Administration commissioner, Dr. Scott Gottlieb, rejected Mulye’s justification for the price hike, saying, “There’s no moral imperative to price gouge and take advantage of patients.”

He said the FDA “will continue to promote competition so speculators and those with no regard to public health consequences can’t take advantage of patients who need medicine.”

The dispute over the antibiotic’s price comes in the midst of periodic complaints by President Donald Trump that drug costs are too high in the United States.

In May, Trump unveiled a plan to try to increase competition among drug makers in an effort to lower drug prices.

“The drug lobby is making an absolute fortune at the expense of American patients,” Trump said.
…

The U.S. Food and Drug Administration is considering a ban on flavored

e-cigarettes in response to an “epidemic” of young people using e-cigarettes, the agency’s leader said on Wednesday.

In a speech at FDA headquarters, Commissioner Scott Gottlieb said the agency would also revisit its compliance policy that extended the dates for manufacturers of flavored e-cigarettes to submit applications for premarket authorization.

“We see clear signs that youth use of electronic cigarettes has reached an epidemic proportion,” Gottlieb said.

Gottlieb announced a number of steps the agency planned to take as part of a broader crackdown on the sale and marketing of e-cigarettes to kids. The agency issued 12 warning letters to companies that it says have deceptive marketing labels on e-liquids. “We cannot allow a whole new generation to become addicted to nicotine,” he said.

Shares of British American Tobacco were up nearly 6 percent and shares of cigarette-maker Imperial Brands PLC were up more than 3 percent. Shares of cigarette and e-cigarette maker Altria Group also rose more than 6 percent, while Philip Morris International shares were up 4 percent.

Traders said proposed FDA action was less harsh than feared. Manufacturers offer and market e-cigarette flavors that appeal to minors, including candy, bubble gum and fruit flavors. The FDA said more than 2 million middle school and high school students used e-cigarettes in 2017.

The FDA is giving the five top-selling e-cigarette brands — Juul Labs Inc., Vuse, MarkTen XL, Blu and Logic — 60 days to provide plans for how they will mitigate sales to minors.

Juul Labs said it would work with the FDA on its request and is committed to preventing underage use of its product. But it added that “appropriate flavors play an important role in helping adult smokers switch,” spokeswoman Victoria Davis said. The owners of Vuse, MarkTen XL, Blu and Logic did not

immediately respond to requests for comment.

“While we remain committed to advancing policies that promote the potential of e-cigarettes to help adult smokers move away from combustible cigarettes, that work can’t come at the expense of kids,” Gottlieb said.

As part of its broader enforcement efforts, the FDA said it issued more than 1,300 warning letters and fines to retailers who illegally sold e-cigarette products to minors.
…

U.S. Defense Secretary Jim Mattis said on Tuesday he would visit Macedonia before a Sept. 30 referendum on changing the country’s name, also expressing concern about suspected Russian interference in the vote, which Moscow denies.

Macedonia scheduled the referendum on the government’s deal in June with neighboring Greece to change its name to the Republic of North Macedonia which would open the door for it to join NATO and the European Union.

“I am concerned about it … The kind of mischief that Russia has practiced from Estonia to the United States, from Ukraine and now to Macedonia, it always has adapted to the specific situation and it’s always beyond the pale,” Mattis, who will visit Macedonia over the weekend, told reporters.

Mattis said he wanted to make it clear the United States supported the Macedonian people.

NATO invited Macedonia to begin accession talks with the alliance, but said it would have to change its constitution and adopt the new name first. The EU has also said it would set a date for Macedonian accession talks pending implementation of the name deal.

Moscow’s ambassador to Skopje has criticized Macedonia’s ambitions to join NATO, saying it could become “a legitimate target” if relations between NATO and Russia deteriorate further.

Greece, a member of both NATO and the EU, has refused to accept the Balkan country’s name, saying it implies territorial claims on the Greek province of Macedonia and amounts to an appropriation of its ancient civilization.

Prime Minister Zoran Zaev’s government, elected in 2017, pushed for an agreement with Greece. Nationalists, including President Gjorge Ivanov, oppose the deal saying it is against the constitution.

In July, Greece expelled two Russian diplomats and barred two other people from entering the country, accusing them of having meddled by encouraging demonstrations and bribing unidentified officials to thwart the Macedonia agreement.

Russia has denied wrongdoing and responded in kind with expulsions of Greeks.
…

Federal and state lawmakers have proposed or adopted a series of measures designed to address the problem of missing and slain Native American women and related issues, such as human trafficking, domestic violence and rape. Among them: 

From Capitol Hill

— Savanna’s Act : The legislation, introduced last fall by North Dakota Sen. Heidi Heitkamp, seeks to expand tribal access to some federal crime databases and establish protocols for handling cases of missing and slain  Native Americans. It also would require annual reports to Congress on the number of missing and slain Native American women. The Democratic senator says if authorities have accurate statistics, they might be able to detect patterns that help solve more cases.

Last year, Heitkamp also launched the #NotInvisible social media campaign to draw attention to this problem.

— End Trafficking of Native Americans Act: The bill, introduced in July by three senators — Heitkamp, Lisa Murkowski, an Alaska Republican, and Catherine Cortez Masto, a Nevada Democrat — would expand efforts to combat human trafficking among Native Americans and Alaska Natives. It would establish an advisory committee to make recommendations to the Justice and Interior departments and a coordinator within the Bureau of Indian Affairs to organize prevention efforts across federal agencies.

— SURVIVE Act (Securing Urgent Resources Vital to Indian Victim Empowerment): This measure would create a tribal grant program within the Justice Department. It would allot 5 percent from a federal crime victims fund for grants that could be used to help tribes assist survivors of violent crimes and set up programs and services, including rape crisis centers and domestic violence shelters.

The bill was reintroduced last year by Sen. John Hoeven, a North Dakota Republican, and has co-sponsors from both parties.

— The National Day of Awareness for Missing and Murdered Native Women and Girls. The Senate unanimously passed a resolution designating the day in memory of Hanna Harris, who was murdered in July 2013 on the Northern Cheyenne Reservation in Montana.

The first day of awareness was May 5, 2017, which would have been Harris’ 25th birthday. A woman and her common-law husband pleaded guilty in Harris’ death, and both were sentenced to prison.

Washington state

In June, a law was enacted that requires the Washington State Patrol to conduct a study to examine how to improve the collection and sharing of information about missing Native American women.

The study also will develop an estimate of how many Native women are missing in the state. “We don’t even know the exact scope of our problem,” said State Patrol spokeswoman Monica Alexander. “We have been told there are hundreds … and nobody is doing anything about it.”

Patrol officials will travel the state to assess the problem and meet with members of the state’s 29 tribes. The patrol will present a report to the Legislature next June.

Montana

The Legislature’s State-Tribal Relations Committee heard testimony this spring that could lead to five bills addressing missing persons. These measures were inspired, in part, by discussions about missing and slain Native American women.

One proposal is called Hanna’s Act, in remembrance of Hanna Harris. It would authorize the state’s Justice Department to assist with the investigation of all missing-person cases and employ a specialist who would act as a liaison between families and law enforcement agencies.

A second proposal would require law enforcement to accept, without delay, reports of missing persons. Harris’ family complained authorities were slow to search for Hanna after they reported her missing.

The committee meets Sept. 7 to decide whether to move the proposed legislation forward. 

Minnesota

A bill to establish a governor’s task force to address the cases of missing and slain Native women in the state failed to pass the Legislature this year. But the chief sponsor, state Rep. Mary Kunesh-Podein, says she is working with activists to gather data and plans to tweak the measure with additional information and reintroduce it in January.
…

For generations, Native American women have been victimized at astonishing rates, with federal figures showing that more than half have encountered sexual and domestic violence at some point during their lives — even amid a wave of efforts aimed at reducing such crimes.

The statistics reinforce arguments that the criminal justice system still fails to protect these women, and its shortcomings again are being exposed as another crisis gains attention: the disappearances of hundreds of Native American and Alaska Native women and girls from across the United States. 

In the past decade, Congress responded to the problem of violence against Native American women with intensely debated legislation seeking to close legal loopholes, improve data collection and increase funding for training of tribal police. Those efforts have proven severely limited, however, prompting advocates to again push for more reforms.

“I think the reason that Native women may go missing at higher rates than other groups of people is very similar to the reason that they are at higher risk for domestic violence and sexual assault,” said Sarah Deer, a University of Kansas professor, member of the Muscogee (Creek) Nation and author of a book on sexual violence in Indian Country. “The legal system is simply not functioning properly [to prevent] these types of things from happening.”

At the end of 2017, the FBI’s National Crime Information Center database had 633 open missing-person cases for Native American women, who make up 0.4 percent of the U.S. population but 0.7 percent of cases in the figures obtained by The Associated Press. African-American women were the only other group to be over-represented in the caseload compared with their proportion of the population.

Figures too low

The numbers are considered an undercount, however, given that reporting is largely voluntary and some tribes didn’t gain full access to the database until 2015, under a Justice Department program launched that year.

Just 47 of the nation’s more than 570 federally recognized tribes are part of DOJ’s Tribal Access Program, which allows them to exchange data with national crime information systems for civil and criminal purposes. The Justice Department has gradually allocated funding to bring more tribes on board, and up to 25 are expected to join the program in the next year, officials said. Other tribes have limited access via state, federal or local law enforcement agencies. 

“We think that’s an important way of ensuring that tribes have the ability to directly deal with the issues on the ground that their families and their community are dealing with,” said Tracy Toulou, head of the Justice Department’s Office of Tribal Justice.

That program was one of many crime-fighting measures in the Tribal Law and Order Act of 2010, which gave tribes authority to hand down longer sentences while mandating that federal officials do more to train tribal police on evidence collection and provide an annual report on Indian Country crime statistics.

Years later, those data collection and reporting efforts are still in development, funding for law enforcement training remains limited, and the Justice Department’s assistance with public safety on reservations — a role referenced in multiple treaties with tribes — has fallen short of officials’ expressed commitment to Indian Country, according to the Justice Department’s Office of the Inspector General.

Prosecutors’ track record

In a 2017 report, the inspector general also highlighted U.S. attorneys’ uneven track record with prosecuting serious violent crimes on reservations, citing data that must be collected under the 2010 law to help improve those prosecution rates. 

Before the law, the U.S. Government Accountability Office found, U.S. attorneys declined to prosecute half of cases on reservations, leading to concerns that the practice was creating a safe haven for criminals on tribal lands. The latest figures, from 2016, show U.S. attorneys declined to prosecute 46 percent of reservation cases, marking only marginal improvement. That included rejecting more than 550 assault and sexual assault cases — more than any other type of crime. (Domestic violence cases typically fall under assault.) Prosecutors blamed the vast majority of rejections on insufficient evidence.

A few weeks ago, at an annual meeting between tribal and federal officials about violence against Native women, Jesse Panuccio, the Justice Department’s acting associate attorney general, identified domestic violence and sex trafficking as two underlying issues that may be linked to disappearances of women in Indian Country. He said improving law enforcement’s response to those crimes could help.

“Many tribal leaders have testified that the disappearance and deaths of American Indian and Alaska Native women are not taken seriously enough, and that increased awareness and a stronger law enforcement response are critical to saving Native women’s lives,” Panuccio said. 

Some tribal leaders and victims’ families contend authorities too often are unwilling to help search for missing loved ones or even file a report.

In Alaska, state authorities — who handle criminal investigations in more than 200 Alaska Native villages — have been accused of classifying fatalities as suicides when families feel certain their loved ones died from a homicide, according to representatives from the Akiak, Emmonak and Tetlin communities. The state, which has the highest percentage of Native residents in the U.S., also has some of the biggest crime disparities in the nation, including the highest rate of women murdered by men. 

A 2013 report found that at least 75 Alaska Native communities had no law enforcement presence, and Alaska Native officials spoke candidly in a federal report last year about barriers victims face in seeking justice. Some victims needing a sexual assault forensic exam must take a boat or plane to an urban area, according to Michelle Demmert, chief justice for the Central Council of Tlingit and Haida Indian Tribes. 

As a result of complaints about police response nationwide, proposals have begun to emerge to address how officers respond, with calls for the Justice Department to establish standardized protocols. 

One of those proposals, included in draft legislation to renew and broaden the Violence Against Women Act, would expand tribal jurisdiction over a range of crimes. For example, tribal police would be able to arrest non-Native Americans suspected of selling women for sex or running trafficking rings. 

A problem of resources

An earlier version of the Violence Against Women Act gave tribal authorities the ability to prosecute non-Indians in domestic violence cases. However, only 18 tribes have met the mandates to do so, the National Congress of American Indians reported in March. Those mandates include requiring tribes to provide an attorney to suspects who cannot afford one — a costly ask for cash-strapped nations. 

“We can’t guarantee that, because we don’t have the funding to guarantee it,” said Robert LaFountain, a prosecutor on Montana’s Crow Reservation, where the per capita annual income of roughly $15,000 is about half the national average. “The funding is always difficult.”

Another measure included in the VAWA reauthorization calls for annual reports on the number of missing and murdered Native Americans, one of multiple federal proposals aimed at measuring the full scope of the problem.

The Violence Against Women Act expires this fall, and prospects for passing any new changes are uncertain. There are no Republican co-sponsors, and the U.S. Justice Department has not signaled its support for amendments. As a senator, U.S. Attorney General Jeff Sessions opposed the legislation in 2013, citing an objection to expanding tribes’ authority over non-Indians and other provisions.
…