FDA not blowing smoke when it comes to ban on flavored tobacco
ROCKVILLE, Md. Weeks after the Food and Drug Administration began enforcing laws against flavored cigarettes, several companies have continued to sell them, the agency announced Friday.
The FDA issued warning letters to companies that have continued selling cigarettes with flavorings designed to mask the taste of tobacco over the Web. Under the Family Smoking Prevention and Tobacco Control Act that President Barack Obama signed into law in June, selling cigarettes with candy, fruit and spice flavorings – with exception to menthol cigarettes – is illegal. The regulation went into effect Sept. 22.
“FDA takes the enforcement of this flavored cigarette ban seriously,” FDA Center for Tobacco Products director Lawrence Deyton state. “These actions should send a clear message to those who continue to break the law that FDA will take necessary actions to protect our children from initiating tobacco use.”
The FDA has told the companies, whose names and specific products were not disclosed, to stop selling flavored cigarettes or eliminate the flavorings.
NACDS mixes support with caution for health bill advancing in House
ALEXANDRIA, Va. In a message of both support and concern, the leader of the National Association of Chain Drug Stores Thursday conveyed guarded support for many of the pharmacy provisions included in a massive health reform bill proposed in the U.S. House of Representatives. But in a letter to House Speaker Nancy Pelosi, D-Calif., NACDS president and CEO Steve Anderson continued the industry’s appeal for changes in the bill’s proposals for reform of the Medicaid pharmacy reimbursement process.
Anderson told Pelosi that many elements of H.R. 3962, the Affordable Health Care for America Act, have the support of chain pharmacy. “This important legislation includes several key priorities for NACDS membership,” he told the Democratic leader, including a reform of the Medicaid payment system for generic drug dispensing, and continued access to durable medical equipment in community pharmacies for Medicare beneficiaries.
“The legislation also paves the way for an expanded role for community pharmacy in a reformed healthcare delivery system through grant programs for pharmacist-provided medication therapy management and the medical home pilot program,” Anderson added. In light of those provisions and their potential to improve patient access, he told Pelosi, “We support the legislative process moving forward.”
However, noted NACDS’ CEO, concerns remain over the “flawed reimbursement system” for Medicaid that was created by the Deficit Reduction Act of 2005. H.R. 3962 “makes significant improvements” to that system by “taking steps to define average manufacturer price in a manner that will result in a more accurate approximation of retail pharmacy’s acquisition costs” for generic drugs, noted Anderson. The bill also “proposes using the weighted average AMP rather than the lowest AMP to set federal upper limits,” which he called “a much needed improvement that takes into account the wide range of market prices for generic drugs.”
All well and good, the pharmacy advocate told Pelosi. However, he added, NACDS still has major concerns with the way AMP is defined under H.R. 3962. Although the bill “rightfully removes pharmacy benefit manager rebates from the AMP definition,” he wrote, “additional changes to the AMP definition are still needed, such as the removal of sales of certain drugs to hospitals, physicians and clinics.”
Chain pharmacy also remains leery of the way Medicaid pharmacy reimbursements are calculated under the legislation, Anderson said, based on its proposal for a “multiplier” of cost plus 30%. “We…remain strongly concerned about the 130% multiplier,” he noted. “We fear that this multiplier will not yield sufficient reimbursement to enable local pharmacies to serve Medicaid patients, especially given the extremely low dispensing fees set by state Medicaid programs.”
Those low rates, he went on, “will likely end the incentives to dispense generic medications, which are critical in controlling prescription drug spending.”
Citing a bill proposed last year by New Jersey Democrat Frank Pallone that called for a multiplier of 300%, Anderson urged Pelosi to revise the legislation to provide a multiplier “considerably higher than 130% to ensure Medicaid patients receive a level of pharmacy access they deserve.”
Takeda enters partnership with Amylin
SAN DIEGO Japanese drug maker Takeda Pharmaceutical Co. is banking on a U.S. pharmaceutical company’s obesity pipeline.
Takeda announced an agreement with San Diego-based Amylin Pharmaceuticals to license, develop and commercialize drugs to treat obesity and related conditions.
The agreement will include investigational drugs from Amylin’s pipeline, such as davalintide and a combination of pramlintide and metreleptin and others from the companies’ obesity research programs. Takeda will pay Amylin $75 million, milestone payments that could reach $1 billion or more and royalties.
“Takeda is excited to realize this partnership with Amylin focused on the treatment of obesity and related indications,” Takeda CEO Yasuchika Hasegawa said in a statement. “By leveraging Takeda’s global development and commercial infrastructure, we look forward to maximizing the significant potential of the products under this agreement.”