Illinois expands medical marijuana for epileptics, minors
Chicago — Illinois Gov. Pat Quinn signed a bill Monday that opens up medical marijuana to treat symptoms of epilepsy in adults and children.
The legislation expands Illinois’ Compassionate Use of Medical Cannabis Act, which came into effect as a four-year pilot program on Jan. 1, to a group previously not included in the original bill.
“This legislation was really an initiative by scores of families in Illinois with children that experience literally hundreds of seizures a day,” the Epilepsy Foundation of Greater Chicago president and CEO Kurt Florian said. “Many of these families have uprooted for treatment in Colorado and have experienced dramatic reductions in seizures from oil-based, low- to zero-THC medical cannabis.”
It’s not only patients with epilepsy who will now be eligible for medical marijuana. The new law — which will take effect in 2015 — also expands the availability of non-smokable medical marijuana to minors with certain conditions who have parental consent.
“My colleagues and I have been deeply moved by the plight of these children and their parents, who courageously and tenaciously pursue any option that could bring relief and better health to their kids,” Chicago’s State Senator Iris Martinez said.
Illinois was the 21st state to implement a medical marijuana program, and the pilot program places restrictions on the number of growers and dispensaries allowed in the state.
Researchers highlight more than 30% decrease in HIV diagnosis rates
CHICAGO — The annual rate of HIV diagnoses dropped by 33% between 2002 and 2011, according to a research letter in this week’s issue of the Journal of the American Medical Association.
The researchers drew on data from legally mandated HIV screenings on individuals older than 13 from 2002 to 2011 in all 50 states and the District of Columbia.
Over the years that the researchers looked at, the number of people diagnosed with HIV per 100,000 went from 35.8 to 26.1 in men and from 13 to 6.9 in women—decreases of 27% and 49%, respectively. The diagnosis also decreased overall for most races and ethnicities—the largest decrease was among Hispanics of any race, with a 41% decrease overall.
There was a 34% decline among cases of HIV contracted from heterosexual contact. However, among cases of HIV attributed to male-to-male sexual contact, there were increased diagnoses within several demographics. The largest increase (132.5%) was among 13- to 24-year-old men who have sex with men.
There were also increased diagnoses among men in that group over 45 years of age, though not one as marked as among the youngest demographic. The increase, though, might be due to the number of 13- to 24-year-olds (typically at high risk) getting tested during this time.
“Although increases in diagnoses were found in young men who have sex with men, reports show that many at high risk do not test annually and the overall percentage of youth who had ever tested for HIV during the period of analysis was low compared with other age groups,” the letter said.
Additionally, HIV contraction through injection drug use was down 70% during the period researchers looked at.
Office of Generic Drugs updates key leadership positions
WASHINGTON — The Food and Drug Administration’s Center for Drug Evaluation and Research is providing an update to key leadership positions within the Office of Generic Drugs, the agency announced. OGD has made assignments, most of which are in an acting capacity, to key OGD subordinate office leadership positions in preparation for Oct. 1 — the beginning of Year 3 of GDUFA when GDUFA goal dates go into effect.
Rob Lionberger will lead the Office of Research and Standards, or ORS, which includes the Division of Therapeutic Performance and the Division of Quantitative Methods and Modeling. John Peters will lead the Office of Bioequivalence, or OB, which includes the three Divisions of Bioequivalence and the Division of Clinical Review. Jason Woo will lead the Office of Regulatory Operations, or ORO, which includes the Division of Filing Review, the Division of Labeling Review, the Division of Project Management, and the Division of Quality Management Systems. Keith Flanagan will remain as transition lead for the Office of Generic Drug Policy, or OGDP, which includes the Division of Policy Development and the Division of Legal and Regulatory Support. Kathleen “Cook” Uhl, M.D. will remain in her current role as acting director of OGD.
According to the FDA, these changes will strengthen OGD’s operations and allow the office to meet the evolving needs of generic drug review. It also will provide higher visibility within the Center and Agency to address generic drugs challenges, and better positions OGD to maximize its efficiency in meeting GDUFA requirements, as demonstrated by the formation of an Office of Research Standards and an Office of Generic Drug Policy.
Generic drugs make up nearly 85% of prescriptions filled in the United States and represent affordable access to treatment for many patients and consumers. These individuals depend on the FDA to ensure that generic drugs perform clinically in the same way as their brand-name counterpart drugs. Transforming OGD into a super office was a critical and necessary step in recognizing the importance of generic drugs to public health and the national economy, the agency said.