FDA to open satellite office in China
WASHINGTON The Food and Drug Administration’s planned office in China will be up and running by the end of the year, the agency announced Thursday.
FDA commissioner Andrew von Eschenbach said the agency will have 60 regulators working at offices around the world over the next year, especially in the Middle East, India and Latin America.
The FDA is setting up the offices due to concerns over unsafe food and drug products imported into the United States.
Congressmen call for more thorough review of direct-to-consumer drug advertising
WASHINGTON Investigating direct-to-consumer advertising of prescription pharmaceutical products, Reps. Bart Stupak and John Dingell, Democrats of Michigan, sent letters Tuesday to companies and government agencies involved.
“We have serious concerns that the leading pharmaceutical companies do not share our commitment to providing consumers with accurate information about drug therapies,” Dingell said in a statement. “As certain drug companies place corporate profits above patient health, it appears they are even willing to ignore FDA recommendations.”
The letters went to FDA commissioner Andrew von Eschenbach, Shaw Science Partners president and EthicAd executive director Michael Shaw, Bayer HealthCare president Gary Balkema and Health and Human Services secretary Michael Leavitt.
In their letter to von Eschenbach, the lawmakers questioned the development of an FDA DTC Web site, “Be Smart About Prescription Drug Advertising: What You Should Know about Prescription Drug Advertisements,” which gives examples of proper and improper DTC ads. A news report showed that the developer of the site as EthicAd, a non-profit organization started by Shaw Science Partners, a public relations firm for the pharmaceutical industry.
According to its Web site, Shaw has worked on the launch of more than 30 drugs, including Johnson & Johnson’s Procrit, which was removed from the market due to safety problems.
“It’s shameful that consumers have to rely on the oversight function of Congress to make sure drug companies tell the truth in their ad campaigns,” Stupak said in the statement.
Letter to the FDA:
Letter to Shaw Science Partners:
Letter to EthicAd:
Letter to HHS:
Letter to Bayer HealthCare:
As election nears finale, legislative goals remain
WASHINGTON As the 2008 presidential election nears its dramatic finale, pharmacy advocates are still pushing for passage in the waning days of the 110th Congress of key legislation to advance their interests, or awaiting a signature from President Bush on bills that have already reached his desk.
Retail pharmacy’s signature victory in 2008 was the enactment in July—over the President’s veto—of the Medicare Improvements for Patients and Providers Act of 2008, or H.R. 6331, which delayed implementation of Medicaid prescription reimbursement cuts, ensured prompt payment of Medicare prescription claims, postponed adoption of burdensome competitive bidding procedures for durable medical equipment under Medicare Part B, and promoted faster adoption of electronic prescribing. But in recent weeks, lawmakers have handed pharmacy a series of smaller victories and opened the door on new, pharmacy-friendly legislation.
One key win was Senate passage late last month of the House-Senate negotiated version of S. 3001, the National Defense Authorization Act for fiscal year 2009. The bill—which at press time was awaiting White House approval—includes an important provision to preserve pharmacy choice for TRICARE beneficiaries.
If signed into law, the bill would preserve the right of U.S. military members and their families to choose where they have their prescriptions filled with passage of a newly revised military spending bill.
The provision would extend the current freeze on increases to retail pharmacy co-payments, thus maintaining a level playing field for retail pharmacies vis-a-vis mail-order pharmacies. Chain and independent pharmacy advocates fought a long struggle to have that provision included in last year’s military spending bill and were buoyed by its inclusion in this year’s proposal.
Retail pharmacy groups also praised the Senate for its passage Sept. 30 of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008. The bill, also expected to be signed by the president, would clamp down on the illegal sale, abuse and trafficking of prescription drugs over the Internet.
Passed in the House of Representatives Sept. 23, the online pharmacy bill would require a valid prescription for the purchase or distribution of any prescription drug over the Internet, issued by a prescribing physician or other qualified professional who has personally examined the patient. However, it would exempt remote-site pharmacies that operate under approved “tele-medicine” procedures.
“This landmark piece of legislation will bring rogue pharmacy operators out of the shadows by establishing a clear standard for legitimate online pharmaceutical sales,” said Michele Leonhart, acting administrator of the Drug Enforcement Administration. The new law, she said, “will allow customers to know they are doing business with a trusted, legitimate pharmacy and give law enforcement the tools we need to identify illegitimate online pharmacies.”
Added Stephen Giroux, president of the National Community Pharmacists Association and an independent pharmacy owner in upstate New York, “There are just some services that should not be available online. This legislation to clamp down on illegal online operators is the first step in the right direction.”
With pharmacy’s support, the Senate also passed another bill last month to strengthen DEA oversight of illegal pharmaceutical activity. If signed into law, S. 1276, the Methamphetamine Production Prevention Act, would spur the adoption of methamphetamine precursor electronic logbook systems, thus providing law enforcement with easier access to information and streamlining record-keeping requirements for pharmacies.
The National Association of Chain Drug Stores praised passage of the bill. “Senate passage of this legislation sends an important message that preventing the illegal production and abuse of methamphetamine is imperative to our nation’s well-being,” said NACDS president and chief executive officer Steven Anderson. “S. 1276 will help law enforcement efforts while also allowing increased efficiency in logging meth precursor sales. We encourage the House to join the Senate in passing this legislation so that it can be enacted into law.”
Another bill on independent pharmacy’s wish list is H.R. 6582, the Small Business Cooperative for Health Care Options to Improve Coverage for Employees [CHOICE] Act of 2008. The bill, introduced by U.S. House Small Business Committee chair Nydia Velazquez, D-N.Y., with support from both parties, is aimed at keeping smaller employers from falling prey to steadily rising health care and insurance costs.
The CHOICE bill has drawn vocal support from the National Community Pharmacists Association. It would set up private, voluntary purchasing cooperatives established under state insurance laws to provide excess claims insurance coverage to participating small businesses. The bill allows those employers to pool health risks over a larger number of insured plan participants, thus reducing costs and, ultimately, premiums.
H.R. 6582 also provides a refundable tax credit to small employers who purchase health insurance for their employees through the cooperative.
Retail pharmacy leaders are also lobbying heavily in favor of legislation to curb the alarming rise of organized retail crime, which drains $30 billion a year from retail businesses, according to NACDS. Congress is currently mulling at least three bills that would combat the problem: H.R. 6713, the “E-fencing Enforcement Act of 2008;” H.R. 6491, the “Organized Retail Crime Act of 2008;” and S. 3434, the “Combating Organized Retail Crime Act of 2008.”
Addressing the U.S. House Judiciary Subcommittee on Crime, Terrorism, and Homeland Security Sept. 22, Walgreens security expert Frank Muscato discussed the growing problem of organized retail theft and its impact on chain drugstores. “ORC is an extremely sophisticated and coordinated crime,” Muscato told the House panel. “It involves highly structured organizations and gangs that hire and control teams of thieves to steal merchandise in large quantities.
“The legislation currently being considered would make ORC a federal criminal offense, which would be extremely helpful in prosecuting more of these large, multi-jurisdictional cases,” Muscato added. “ORC is not garden variety shoplifting. It is organized crime and should be treated as such with stronger penalties and enforcement.”