Another local government is considering forcing drugmakers into the waste management business.

San Francisco's Board of Supervisors is proposing an ordinance that would make biopharma companies responsible for collecting and disposing of unused prescription and nonprescription drugs used by city residents. If implemented, the mandatory "drug stewardship" program would replace a voluntary drug take-back pilot program managed by 13 pharmacies and local law enforcement.

The drug industry has been picking up about 40 percent of the tab for the pilot program, which includes 23 drop-off sites. Since the program's launch in 2012, it has collected more than 37,000 pounds of unused drugs, according to the proposed ordinance. But San Francisco officials think more collection sites are needed and drugmakers should pay for the program.

Under the proposal, drugmakers would cover nearly the entire cost of setting up, running and promoting an expanded collection/disposal system. In addition to maintaining at least five secure drop-off sites in every supervisorial district of the city, drugmakers would have to offer a mail-back service. The ordinance prohibits companies from passing the cost on to local consumers via fees.

If it passes the ordinance, San Francisco would be the third local entity in the country to require drugmakers to collect and dispose of unused drugs. Alameda County, Calif., became the first when it adopted a similar rule in July 2012. King County, Wash., followed suit last year.

The Biotechnology Industry Organization, Generic Pharmaceutical Association and Pharmaceutical Research and Manufacturers of America (PhRMA) challenged the county ordinances, claiming they violated the federal Commerce Clause, shifted local government responsibilities onto the back of interstate businesses and transferred the cost of local drug disposal to patients in other states. (See BioWorld Today, Dec. 4, 2013.)

A few weeks ago, the U.S. Court of Appeals for the Ninth Circuit upheld the Alameda ordinance, saying it was constitutional because it did not discriminate against or directly regulate interstate commerce. The appellate court's decision in PhRMA v. Alameda also will apply to municipalities and counties in Washington, which is part of the Ninth Circuit.

In proposing their ordinance, San Francisco officials noted that other countries – including France, Spain and Portugal – have nationwide drug stewardship programs. Canada is doing it province by province. British Columbia implemented a drugmaker-sponsored take-back program in 1996; Manitoba and Ontario implemented their programs more recently.

Since drugmakers can share a stewardship program, the cost per county or city could be relatively low. Alameda officials, for instance, estimated that the annual cost of complying with their ordinance would be from $5,300 to $12,000 per manufacturer. Those costs would add up though as more countries and local governments make drugmakers responsible for waste collection.

SOC RISKS MAY REQUIRE CONSENT

Responding to the furor raised last year over an NIH-funded neonatal trial, HHS' Office for Human Research Protections (OHRP) is releasing a draft guidance specifying when the risks of standard of care (SOC) must be included in the informed consent for a clinical trial.

"The key issue is not whether an intervention provided to subjects is within a standard of care, but whether the treatment a subject receives (and thus the risks they are exposed to) is different from that which these subjects would have been exposed to outside of the research study," OHRP said in a notice slated for publication in Friday's Federal Register.

Thus, if a trial involves reasonably foreseeable risks the subjects would not have otherwise been exposed to, those risks should be spelled out in the informed consent. "Only in this way can people make a truly informed decision about whether they are willing to participate," OHRP added.

The guidance will apply to studies such as comparative-effectiveness research that evaluate SOC. In the SUPPORT trial, which triggered the debate over SOC informed consent, researchers studied the appropriate oxygen saturation level in infants with extremely low birth weight. (See BioWorld Today, April 17, 2013.)

Because both oxygen ranges studied in the trial were within SOC, the informed consent said there was no predictable increase in risk for the infants. Trial results showed that 8.6 percent of the 475 infants in the lower oxygen group developed severe retinopathy of prematurity, which can lead to blindness, as compared with nearly 18 percent of the 509 babies in the higher oxygen group. But nearly 20 percent of the infants in the lower oxygen group died, compared with about 16 percent in the other group.

Comments on the draft guidance are due by Dec. 23.

TB BIGGER PROBLEM THAN EXPECTED

The global tuberculosis (TB) burden is higher than previously thought. That's the conclusion of the World Health Organization's (WHO) Global Tuberculosis Report 2014.

Attributing the increase to better data collection, the report shows that 9 million people developed TB in 2013 – about 500,000 more than expected – and 1.5 million died. About 480,000 new cases of multidrug-resistant TB occurred in 2013, with severe epidemics in Eastern Europe and Central Asia. Extensively drug-resistant TB, which is even more expensive and difficult to treat, was reported in 100 countries.

"The report . . . underlines that a staggering number of lives are being lost to a curable disease and confirms that TB is the second biggest killer disease from a single infectious agent," the WHO said.

The good news is that the number of people contracting TB continues to decline by about 1.5 percent a year and the mortality rate has dropped by 45 percent since 1990.

To combat the continuing problem, the WHO estimated another $2 billion is needed each year.

EMA INVITES EBOLA DATA

In an open invitation to drugmakers, the EMA said it's ready to assess data for potential Ebola vaccines and treatments. It's just waiting for companies to submit the data.

The agency has set up a rolling review process that "allows experts to continuously assess incoming data and develop increasingly robust scientific opinions," the EMA said. It will share its initial review and updates with health care decision-makers in other countries, including those hit the hardest by Ebola.

Having the data will enable officials in West Africa to make informed decisions on whether and how they want to use the vaccines or drugs in the ongoing Ebola outbreak. "In the current emergency situation, we accept that the benefit-risk balance is determined largely by the public health need," said Tomas Salmonson, chairman of the EMA's Committee for Medicinal Products for Human Use.