Latest Drugwonks' Blog
Texas won’t allow Canadian drugs after all
A new state law intended to help Texas consumers buy less
expensive prescription drugs from Canada was struck down Wednesday by
Attorney General Greg Abbott, who ruled that it violated federal law.
The attorney general said the statute violates the federal Food, Drug
and Cosmetic Act, which “makes it an offense not only to import, but to cause the importation of prohibited medications.”
Abbott, whose jurisdiction covers only Texas law, said similar proposals in Maryland, Tennessee and Vermont have encountered legal challenges.
Can FDA do more to speed the advance of cancer treatments? Of course. But FDA hasn’t been idle. Consider the agency’s existing initiatives to help make innovative therapies available more quickly and at a lower total cost while maintaining high standards of consumer protection.
FDA has already made great strides:
* Reducing drug development times by avoiding multiple review cycles
* Improving the review process through a quality systems approach to medical product review
* Supporting innovation in medical products by clarifying regulatory uncertainty and increasing predictability in product development
FDA has been available and engaged in constant communication sponsors early on in the review process including:
* End of Phase II meetings
* Pre-NDA meeting
* Post-NDA Submission meeting being piloted by the Oncology Division
FDA has requested and approved comprehensive development programs in advance of “Fast Track” designations, helping to ensure clinical trials are properly structured:
* Using newly developed Special Protocol Assessment guidance, product developers work more closely than ever before with the FDA to create phase III studies prior to implementation to gather all necessary information
* FDA’s call for the use of a Continuous Marketing Application enhances sponsor access to early guidance and feedback for Fast Track drugs or biologics intended to treat serious or life threatening diseases, and provides for FDA-sponsor agreement to engage in frequent scientific.
In addition to early and frequent communication, FDA’s quality systems approach to medical product review has facilitated the regulatory review process through:
* The implementation of the Common Technical Document (CTD) and the electronic CTD (eCTD), which uses cutting edge technology and combined with international public health policy to provide better quality, consistency and communication with sponsors. Another key component to this program is the development of new medicines by creating clearer guidance for product approvals in priority areas (e.g., obesity, diabetes and oncology).
* The Special Protocol Assessment (SPA), guidance was created to help product developers design phase III trials that will ensure necessary data is being collected. In addition, the FDA works closely with sponsors to review and approve a comprehensive development program in anticipation of Fast Track designation and the potential filing for Accelerated Approval. This includes phase III confirmatory studies —a major theme repeatedly mentioned as a criterion for accelerated approval.
Overall, these and other initiatives are designed to help the FDA achieve its public health mission of promoting and protecting patient health by reducing time to market for new medical products such as Nexavar — resulting in earlier patient access to safe and effective treatments.
Do more? Sure. But credit where credit is due for important reforms already designed and implemented.
My 18 year old son has epilepsy and so I bring you the following news with gratitude and excitement and courtesy of the FDA website. The full story can be found at www.fda.gov.
The Food and Drug Administration announced today that a drug to treat seizures, has become the 100th medicine to have new information for children and teenagers included in its labeling. Under eight years of legislation to enhance pediatric drug information, 100 pediatric drugs now include additional labeling information on safety, efficacy, dosing and unique risks for children.
The Federal Food, Drug, and Cosmetic Act (as amended by the Food and Drug Administration Modernization Act of 1997 — FDAMA) and the 2002 Best Pharmaceuticals for Children Act (BPCA), provides incentives to companies who perform research to determine the safety, efficacy, dosing and unique risks associated with medications for children, based on the same level of scientific evidence required for adults.
Under the law, FDA works with the larger pediatric community to determine which products should be studied in the pediatric population based on the public health needs of children. FDA has issued more than 300 requests for studies of medications, based on either the frequent use or the potential use of those medicines in the treatment of children, or on the need for pediatric information so the drugs may be used to treat disorders for which children have few or no other options. Since FDAMA was enacted in 1997, manufacturers have conducted more than 250 pediatric studies for 125 products. By comparison, in the 7-year period before FDAMA was enacted only 11 such studies were conducted. The studies from 114 products responded to the requests by FDA and these products have been granted six months of additional marketing without generic competition.
“The studies were conducted for a wide range of childhood conditions, such as asthma, HIV, seizures, juvenile rheumatoid arthritis, pain management, diabetes, high blood pressure, attention deficit hyperactivity disorder, brain tumors and leukemia,” said Steven Galson, MD, Director of FDA’s Center for Drug Evaluation and Research. “They have resulted in important new pediatric information in 100 new drug labels and additional drugs are presently being studied to further protect our children from any serious side effects.”
I hope that those who are quick on the draw to criticize the FDA are penning notes of congratulations in advance of the holiday break.
The Associated Press
SAN FRANCISCO — Customs agents have intercepted more than 50 shipments of counterfeit Tamiflu, the antiviral drug being stockpiled in anticipation of a bird flu pandemic, marking the first such seizures in the U.S., authorities said Sunday. The first package was intercepted Nov. 26 at an air mail facility near San Francisco International Airport, said Roxanne Hercules, a spokeswoman for U.S. Customs and Border Protection.
Since then, agents have seized 51 separate packages, each containing up to 50 counterfeit capsules labeled generic Tamiflu. The fake drugs had none of Tamiflu’s active ingredients, and officials were running tests to determine what the capsules did contain. Initial tests indicated some vitamin C in the capsules, said David Elder, director of the Food and Drug Administration Office of Enforcement. Information on the packages was written in Chinese, but it is unclear where the drugs originated, Elder said. They were sent by Asian suppliers to individuals who placed orders over the Internet, Hercules said. She said none of the shipments intercepted so far was bound for doctors or hospitals. Agents became suspicious because Tamiflu is produced by Swiss pharmaceutical manufacturer Roche, and there is no generic version available. “What we’re trying to do is alert the American public that they shouldn’t be buying this product because we may never be able to track down the manufacturers,” Elder said Sunday. “We’ve anticipated the likelihood of counterfeits from the very beginning. People are trying to profit on the heightened concerns of the American public.”
An investigation conducted by the U.S. Food and Drug Administration found a significant percentage of drugs touted as Canadian and shipped from Internet pharmacy websites claiming to be Canadian were not actually from Canada, the agency announced Friday.
The FDA said nearly one-half of the imported drugs intercepted from four selected countries were shipped to fill orders consumers believed had been placed with Canadian pharmacies. Of the drugs that were promoted as Canadian, 85 per cent actually came from 27 countries around the globe and a number were counterfeit, the agency said.
“These results make clear there are Internet sites that claim to be Canadian that, in fact, are peddling drugs of dubious origin, safety and efficacy,” FDA acting commissioner Dr. Andrew von Eschenbach, said in a statement.
“We believe that these bait and switch tactics — offering patients one thing and then giving them something else — are misleading to patients and potentially harmful to the public health.”
The FDA conducted its operation in August 2005 at JFK Airport in New York City, Miami International Airport, and Los Angeles International Airport. Agency officials examined all mail parcels suspected of containing pharmaceuticals sent from four countries — India, Israel, Costa Rica, and Vanuatu — that the FDA had previously noticed were sources of drugs apparently ordered from pharmacies alleged to be Canadian in origin. Out of nearly 4,000 parcels examined, about 43 per cent had been ordered from purportedly Canadian Internet pharmacies and the drugs were represented as being of Canadian origin. But only 15 per cent of those examined actually originated in Canada. And 32 of the medications were determined to be counterfeit.
Paul Krugman (the New York Times editorialist) in his 12/16 op-ed points to the “medical-industrial complex” as rife with conflicts of interest, avarice, and invention (and not “invention” as in “the mother of invention”). Mr. Krugman’s White Knight? Why none other than Dr. Eric Topol. His favorite “expert?” None other than Marcia Angell. Get the picture? And when he lists the tools in the pharmaceutical industry’s arsenal of “persuasion” he commences his litany with - ready? — “cheerleaders as sales representatives.” As Casey Stengal would say, “you can look it up.” Here’s the infuriating part, “Prescription drugs and high technology medical devices account for a growing share of medical spending.” Sound familiar? Does he know (or care) that the “growing share” is about 12 cents on the health care dollar? Is he naive enough to believe that acute care is all and chronic care is but a bagatelle; that rather than getting more people on statins we should strive to lower the prices of diabetic amputations? And here’s the annoying part, “In future columns I’ll talk about how serious health reform can reduce the conflicts of interest that are tainting our current system.” I can’t wait. To once again quote the Ol Perfessor, “They say you can’t do it, but sometimes it doesn’t always work.”
Here is Bob Goldberg’s op-ed that appears in today’s edition of the Washington Times.
The much-derided “bridge to nowhere” in Alaska was blown up before Thanksgiving. It had become, as the Wall Street Journal observed, “the poster child for Republican fiscal extravagance and the object of justified ridicule across the political spectrum.” The bridge to nowhere is, however, a mere footpath compared to Sen. Chuck Grassley’s highway of hubris: a back-alley abrogation of existing law that will protect a handful of drug companies from competition at a cost to consumers of about $5 billion over two years.
Mr. Grassley has always used a combination of whistle-blowing hearings and dead-of-night amendments to make his mark by himself. But now, Mr. Grassley’s arrogance and impunity in shoving this scam down the throats of the American people shows that he’s one reason why rank-and-file Republicans believe their party has veered from both principles and probity in their governance of the nation.
Mr. Grassley’s particular peeve is that brand drug companies under a law designed to promote generic drug competition (the Hatch-Waxman Act) are doing just that — pricing their products to compete against a generic product once the brand’s patent expires and a generic enters the market. Brand products at generic prices are commonly called “authorized generics.” The Food and Drug Administration, Federal Trade Commission and a Federal Appeals Court have made it clear that Hatch-Waxman allows for this competition. As the court has noted, nothing prevents a brand company from marketing its product as a generic. Indeed, doing so is consistent with the objective of the Hatch-Waxman Act (the Drug Price Competition and Patent Term Restoration Act).
To prohibit a brand company from marketing its product as a generic drug would require a change in statute. Mr. Grassley asked the FTC to re-examine the impact of authorized generics on competition but apparently isn’t interested in waiting for its report or relying on hearings to further vet the issue in the committees that have actual jurisdiction over generic drugs. His end run around Hatch-Waxman is an extended index finger to the agencies and courts that have ruled on the measure. It forces brand firms that launch or license generic versions of brand products to sell any remaining brand products on the market at the generic price to Medicaid and eventually Medicare. Historically, that’s about 15 percent of a product’s sales the first year or so after a generic hits the market.
So, in effect, Mr. Grassley is slapping a price control on innovative companies as a penalty for proceeding with generic competition. He and his health-care policy director Mark Hayes have stated that they hope the measure will discourage generic introductions from brand companies. The Senate Finance Committee, which Mr. Grassley chairs, does not have jurisdiction over Hatch-Waxman. But that little detail hasn’t deterred the Grassley-generics industry alliance.
If it does, their victory of arrogance will come at the expense of taxpayers and consumers. Over the next two and a half years about $60 billion in brand drugs will become generic; $30 billion of that will be sold without competition for 180 days if Mr. Grassley gets his way. And many other generic drugs that are difficult to make or have limited supplies of raw materials will continue to not have any Authorized Generic competitor.
Historical pricing data shows that brand companies launch their generics at a 50 percent discount off retail price compared to a 30 percent discount experienced when a generic drug has no competition. If Mr. Grassley gets to override existing law and judicial precedent, consumers and taxpayers over the next two years would see about $8 billion in savings instead of $13 billion in savings. The bridge to nowhere cost about $250 million. With Mr. Grassley’s power grab, at a cost to consumers and taxpayers of $5 billion, 25 bridges to nowhere could be built. The $5 billion will line the pockets of a handful of generics companies.
This hijacking of Hatch-Waxman is unfortunately not as clear a target to deride as the bridge to Gravina Island. Flouting both congressional intent and the judgment of a federal appeals court, which would kill competition and cost consumers billions, cannot be easily conveyed in a sound bite. But the abuse of power is more brazen.
Abraham Lincoln observed, “Nearly all men can stand adversity, but if you want to test a man’s character, give him power.” Voting down the Grassley proposal would be a true test of character for Republicans. It would be a vote for the rule of law, a rejection of political arrogance and a rebuke to the Republican Party’s disregard for liberty and free markets in recent months.
At stake is the integrity of the legislative process, the respect for our republican form of government and the reputation of the party.
Here’s a bit of research that hasn’t appeared in any major (or minor) media as far as I can tell. If you know Senator Grassley, please feel free to pass it along.
* The vast majority of physicians (85%) are confident in the safety of the drugs approved by the FDA.
* 86% of doctors are confident that the FDA has strict and stringent standards for determining if a drug is safe.
* Nearly three quarters of physicians (71%) indicated that FDA approval is one of the most important factors to consider prior to prescribing a medication.
The survey was conducted by HCD Health and the Muhlenberg College Institute of Public Opinion. They surveyed a nationally representative sample of 1,039 primary care physicians.
The New York Times’ breaking news on cheerleaders as pharmaceutical detailers and the Wall Street Journal’s hard-hitting expose on professional medical writers both appeared on the front-pages of these national newspapers of record. Today’s story on a Pfizer-funded $100 million, 20,000 patient study on Celebrex (headed by the Cleveland Clinic’s well-respected cardiologist, Dr. Steven E. Nissen) appeared on pages C3 and D5 of the New York Times and the Wall Street Journal respectively. What is wrong with this picture?
I am queried by a DrugWonks reader as to whether any of the medical ghostwriters vilified in the below-referenced WSJ article have at any point also been cheerleaders.