Plan to reorganize FDA’s Office of Generic Drugs receives approval
WASHINGTON — The Food and Drug Administration’s Office of Generic Drugs will be elevated to a "super office," a top official in the agency told staff members in a memo Monday.
Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, of which the OGD is a part, said the elevation of the office meant it would house subordinate offices within its organizational structure and would report directly to her, with acting director Kathleen Uhl continuing in that role. Woodcock said the reorganization, plans for which were originally announced in September 2012, would strengthen the OGD’s operations and allow it to "meet the evolving needs of generic drug review."
"Transforming OGD into a super office is a critical and necessary step in recognizing the importance of generic drugs to public health and our national economy," Woodcock wrote. "As a super office, OGD will coordinate and manage the abbreviated new drug application review process, provide safety, surveillance, clinical and bioequivalence reviews for generic products, as well as contain new offices to develop policy and regulatory science for generic drugs."
The new structure of the OGD will include an Office of Research and Standards, an Office of Bioequivalence, an Office of Generic Drug Policy and an Office of Regulatory Operations, each of which will have multiple divisions under it. Members of a transition team will lead the offices.
Generic drug prices spike, but PBMs’ reimbursement rates don’t keep up, NCPA study finds
ALEXANDRIA, Va. — A survey of more than 1,000 independent pharmacists finds that acquisition costs for generic drugs have spiked by as much as 1,000% this year.
The survey, conducted by the National Community Pharmacists Association, said that patients were paying more for drugs and often going without them, particularly Medicare and Medicaid patients, and many patients are declining medications due to increased co-pays. Higher co-pays and larger charges to drug plans also are pushing seniors into the "donut hole" coverage gap of Medicare.
"Once generic drugs become available, lower costs typically follow, and community pharmacists are leading the way to maximize the savings for patients and health plans from the proper use of generics," NCPA CEO B. Douglas Hoey said. "However, pharmacy acquisition costs for more and more generic drugs are rising in rapid, breathtaking fashion. This is having a negative impact on a number of patients, particularly Medicare beneficiaries. Meanwhile, reimbursement from pharmacy benefit managers is not keeping up, leaving pharmacists out in the cold and putting patient access to pharmacist care on unsustainable footing."
According to the survey, 77% of pharmacists reported 26 or more instances of a large upswing in a generic drug’s acquisition price over the past six months, while 86% said it took the PBM or another third-party payer from two to six months to update its reimbursement rate, but it was not done retroactively. In addition, 84% said the acquisition price spike and lagging reimbursement trend has a "very significant" effect on their ability to remain in business to continue serving patients. In some cases, pharmacists were faced with having to refrain from filling prescriptions that would have caused them to lose up to $100 or more per prescription.
Generic drugs most frequently cited included the blood pressure drug benazepril; the antidepressant clomipramine; the heart rate drug digoxin; the psychiatric drug divalproex; the asthma drug budesonide; the pain drug morphine and many others. The report noted that the causes of the price increase are uncertain.
"In an era of instant communication, it is indefensible for PBMs to wait weeks or even months before updating their payment benchmarks in the wake of these price spikes without ever reimbursing pharmacies retroactively," Hoey said. "Pharmacists’ appeals to PBMs to update payment rates are consistently denied or ignored. This situation is untenable for small business community pharmacies, and we urge PBMs to update their reimbursements."
Giant Eagle acquires Rx21 Specialty Pharmacy, enabling enhanced hepatitis C/organ transplant services
PITTSBURGH — Giant Eagle on Monday announced the acquisition of Rx21 Specialty Pharmacy, enabling the company to provide enhanced services to Hepatitis C and organ transplant patients and providers.
"[This will] improve our ability to help patients manage Hepatitis C and transplant conditions with enhanced clinical, operational and mail capabilities," stated Brett Merrell, Giant Eagle SVP health and wellness. "We greatly value the expertise gained with the new acquisition of Rx21, particularly at a time when two significant new Hepatitis C treatments are becoming available."
"Giant Eagle’s commitment to delivering specialty medications with value added services, such as patient education, financial counseling and prior authorization assistance for the doctors, makes for a perfect partnership with Rx21," said Rx21 owner David Hollis. "This collaboration also will give Rx21 patients the option to pick up medications at Giant Eagle Pharmacy locations, creating an unmatched patient experience."
In addition to access to Rx21’s expertise and clinical support, Giant Eagle Specialty Pharmacy customers suffering from Hepatitis C and transplant conditions now have 24-hour-a-day access to pharmacists ready to provide counsel on medication management.
The Food and Drug Administration recently approved Olysio (simeprevir) for use as treatment by those suffering from Hepatitis C, and is expected to approve a similar new drug, sofosbuvir, soon. These medications could offer a more effective approach to treating and eliminating Hepatitis C.
Services available to all Giant Eagle Specialty Pharmacy customers include:
- Full support of prior authorizations;
- Coordination of financial assistance, including co-payment assistance for eligible prescriptions;
- A dedicated team of patient care advocates supporting patients regularly throughout their treatment;
- Routine communication and updates with doctors’ offices;
- Drug administration counseling, including injection training when patients begin therapy;
- Regular refill reminder calls; and
- Specialty medications and pharmacy services are used in the treatment of chronic conditions and in complex treatment regimens for cancer, Hepatitis C, rheumatoid arthritis, psoriasis, Crohn’s disease and multiple sclerosis.
Medications used to treat these conditions often are significantly more complex than traditional prescriptions, and in many occasions, may involve financial aid and ongoing management of side effects, dosage changes, refills and adherence.