New FDA rule eases access to investigational drugs for gravely ill
ROCKVILLE, Md. The Food and Drug Administration published two rules Wednesday designed to expand patient access to investigational drugs.
The agency said the rules are designed to clarify methods that seriously ill patients can use to gain access to investigational drugs when they’re ineligible to participate in clinical trials and don’t have other satisfactory treatment options. It also launched a Web site where patients and their doctors can learn about options for receiving investigational drugs.
One rule, “Expanded Access to Investigational Drugs for Treatment Use,” expands availability of investigational drugs by clarifying procedures and standards. The other, “Charging for Investigational Drugs Under an Investigational New Drug Application,” clarifies circumstances and costs for which a manufacturer can charge patients for a drug when it’s used inside or outside of a clinical trial.
“With these initiatives, patients will have the information they need to help them decide whether to seek investigational products,” FDA commissioner Margaret Hamburg said. “For patients seeking expanded access to investigational drugs and biologics, the new rules make the process easier to understand.”
MinuteClinic offering new rapid pink eye test in Atlanta market
ATLANTA MinuteClinic, in partnership with Rapid Pathogen Screening, is offering a new rapid pink eye test at its 23 locations inside select CVS/pharmacy stores in the Atlanta area, and hopes to eventually offer the test nationally at all its clinic locations in 25 states.
“MinuteClinic patients will get on-the-spot results that provide a more precise pink eye diagnosis,” stated Donna Haugland, MinuteClinic chief nursing officer. “This helps prevent the overuse of antibiotics and can lead to prescription savings.”
Conjunctivitis, or pink eye, is an infectious — and frequently highly contagious — condition that is most often caused by either a virus or bacteria. It is often spread among children in close environments such as schools, camps and recreational activities.
Until now, the accurate diagnosis and appropriate treatment of pink eye has been difficult, according to MinuteClinic. While treatment with antibiotics is only necessary in 40% to 60% of cases, the majority of medical professionals prescribe antibiotics nearly 100% of the time.
Indiscriminately prescribing antibiotics compounds the side effects associated with their overuse and increases patient resistance to these medications.
The cost for conjunctivitis treatment is $77.
Survey finds most moms do not keep kids up to date with vaccinations
NEW YORK A new survey released last week reports that most moms know their children need additional vaccines beyond those received when they were infants or small children. But according to Centers for Disease Control and Prevention estimates, most pre-teens and teens do not have all the vaccinations that the agency recommends.
The survey, conducted by Harris Interactive, with support from Merck, found that 4-out-of-5 moms of pre-teens and teenagers agree that pre-teens and teenagers need additional vaccines beyond those they received when they were younger.
“These results mirror what I see in my own practice — a lot of adolescents not up to date on their vaccines, in spite of their parents awareness of the need for them,” stated Lolita McDavid, a pediatrician practicing at Rainbow Babies and Children’s Hospital in Cleveland, Ohio. “Taking your kids — including pre-teens and teens — for an annual check-up should be as routine as buying them school supplies. I encourage all moms to schedule an appointment with their child’s health care professional today and to visit www.cdc.gov to learn more about the vaccines recommended for pre-teens and teens.”