Latest Drugwonks' Blog
From the Pink Sheet:
Data Exclusivity Remains A Top Issue In USTR's 2011 Special 301 Report
The failure of U.S. trading partners to adequately protect pharmaceutical test data remains one of the top concerns of the United States Trade Representative in its 2011 Special 301 Report on intellectual property rights.
The report encourages several countries to protect against unfair commercial use and unauthorized disclosure of undisclosed test or other data generated to obtain marketing approval of pharmaceutical products. The countries cited include Algeria, Argentina, Chile, India, Indonesia, Pakistan, Brazil, Dominican Republic, Ecuador, Egypt, Malaysia, Mexico, Turkey and Paraguay.
In its annual Special 301 report, the USTR places U.S. trading partners deemed to provide insufficient IP rights protection, enforcement or market access on a Priority Watch List, Watch List or Section 306 monitoring list. Of 77 trading partners reviewed, the USTR put 12 countries on the Priority Watch List, 29 on the Watch List, and one, Paraguay, on the monitoring list. China, India, Israel, Thailand and Venezuela are among those on the Priority Watch List.
The report, released on May 2, includes an extensive discussion of China. It notes that pharmaceutical manufacturers have reported positive results from China's "Program for Special Campaign on Combating IPR Infringement and Manufacture and Sales of Counterfeiting and Shoddy Commodities," which was launched in October 2010.
"According to rights holders in this sector, law enforcement has been reaching out to individual companies, investigating leads early on, and bringing criminal prosecutions against infringers," the report states. "Rights holders detect more diligence and promptness on the part of Chinese authorities in developing criminal counterfeit pharmaceutical cases."
However, the report says the United States is troubled by China's May 2010 prosecution guidelines that tripled the threshold for investigating and prosecuting trade in counterfeit goods.
Christopher Singer, Pharmaceutical Research and Manufacturers of America President, International, said in a statement on the report that China "continues to circumvent data protection obligations and permit widespread distribution of unregistered active pharmaceutical ingredients."
Singer also said India has had significant delays in providing data protection and expressed concern about the scope of patents and coverage of incremental innovation, delays in providing patents and recent court actions to limit or undermine patentablility. He also expressed support for USTR's out-of-cycle review of Thailand, saying the country's "weak protection" of IP rights is especially troubling.
While Japan, Poland and New Zealand did not make either watch list, the USTR singled them out in the report, citing the pharmaceutical industry's concerns about their policies.
U.S. industry has "expressed serious concerns about the policies and operation of New Zealand's Pharmaceutical Management Agency," including the transparency, fairness and predictability of its pricing and reimbursement regime, the report states.
The report says industry also is concerned about health care reform legislation introduced in Poland in 2010 that would alter the country's pricing, reimbursement and clinical trials policies. The report also notes that the pharmaceutical industry is upset that it has not been able to meet with Poland's Ministry of Health to discuss these initiatives.
As for Japan, USTR says it is seeking further improvements in transparency and reform of reimbursement and regulatory systems that "would facilitate the timely introduction of innovative pharmaceuticals and medical devices into Japan's market."
The 2011 report is similar to last year's. In addition to data exclusivity, the USTR also reiterates its concerns about patent laws in India and the Philippines that prohibit patents on certain chemical forms unless they show increased efficacy.
Despite making major concessions to the United States, Israel remains on the Priority Watch List. Last year, it reached an understanding with the U.S. to strengthen laws on protection of pharmaceutical test data and patent term extension and to publish patent applications 18 months after the application is filed. While Israel has submitted legislation for the protection of pharmaceutical test data, the report says it has not submitted legislation regarding patent term extension or patent publication.
Compulsory licensing, once a major issue for USTR, is mentioned only with respect to China and Ecuador. China's draft regulations for patenting technologies used in national standards may allow a compulsory license if a patent holder does not grant a royalty-free license. As for Ecuador, the report says simply that the U.S. "will continue to monitor developments concerning compulsory licensing of pharmaceutical and agricultural chemical products."
Jamie Love, director of Knowledge Ecology International, an organization that closely tracks IP and trade policy, said the report does not convey the arm twisting that goes on behind the scenes.
"The USTR discussion of IPR policy concerns seems muted in the report, compared to the pressure that the U.S. government actually applies both behind the scenes and in different trade fora," Love said in a blog posting. "In practice, the 301 Report represents only a fraction of the issues being raised and the pressures being applied by the White House and various federal agencies."
Industry also is concerned about the inclusions of IP rights in a regional trade agreement currently in development, the Trans-Pacific Partnership (TPP) Agreement. The United States and its TPP partners - Australia, Brunei Darussalam, Chile, Malaysia, New Zealand, Peru, Singapore and Vietnam - held their sixth round of negotiations in Singapore last month and are to hold the seventh round the week of June 20 in Vietnam. The U.S. expects the agreement to increase American exports to the Asia-Pacific.
PhRMA is advocating for a strong IP chapter. In an April 2011 document, "PhRMA Views: Intellectual Property (IP) Chapter for the Trans-Pacific Partnership (TPP) Agreement," the association said data protection is essential to recoup R&D expenses. It cites the provision in the U.S. health care reform law that provides 12 years of data exclusivity - the time during which a generic or other competitor cannot use clinical data generated by an innovator to obtain marketing approval - for biologics.
PhRMA also says countries should be required to provide patent term adjustments to compensate for the loss of effective patent term from delays in marketing approval and the issuance of a patent. And it says the TPP "must include a mechanism to permit a patent owner to resolve patent infringement issues prior to marketing approval of the infringing pharmaceutical product."
From the pages of the New York Times:
Doctors' Prescription Records
To the Editor:
A recent Business Day article reported that the Supreme Court will review a Vermont law that limits the sale of doctors’ prescription records (“A Fight Over How Drugs Are Pitched,” April 25). The high court should invalidate the law. Not only is it redundant, it also undermines federal efforts to promote drug safety.
The American Medical Association already runs a national program that allows doctors to opt out of having their data available for sale. There is no need for states to duplicate its efforts.
Further, pharmaceutical companies rely on physicians’ prescription records to disseminate F.D.A.-directed safety warnings. Without access to doctors’ prescription data, they don’t know how many patients are taking specific drugs, or for how long. Such data are crucial to addressing safety issues quickly.
PETER PITTS
New York, April 25, 2011
The writer is president of the Center for Medicine in the Public Interest and a former F.D.A. associate commissioner.
www.chicagotribune.com/health/ct-health-chat-pseudoscience,0,4487863.htmlstory
Avoiding Internet pseudoscience
Join us at noon CT (1 p.m. ET/10 a.m. PT) on Tuesday, April 19, for an hour-long chat about filtering through pseudoscience on the Internet, with the Tribune's health reporter Trine Tsouderos and panelist Robert Goldberg.The Internet has become a major source of medical information for millions of us as we wonder what might be causing our headache, what to do about our child's hyperactivity, whether we should be worried about that mole or not, whether homebirth is safer than hospital birth. We Google cures for cancer, silver bullet weight loss strategies, treatments for autism and risks associated with vaccines.
Are we better informed? Or are we bathing in a tub of bad information and even undermining our own health? Join journalists Trine Tsouderos and Robert Goldberg for an hour-long discussion of the Internet as a source of medical information and misinformation. We'll be discussing how to avoid slipping in puddles of pseudoscience and instead, how to become an astute consumer of online medical information. In a national PEW Study, find out what type of health advice people ages 18 and up are most likely to look for online and who is most likely to look for health advice online.
Journalist Robert Goldberg is the author of "Tabloid Medicine: How the Internet Is Being Used to Hijack Medical Science for Fear and Profit." Co-host of the blog www.drugwonks.com, Goldberg's work has appeared in the Wall Street Journal and Los Angeles Times. He is also vice president of the non-profit Center for Medicine in the Public Interest.If you would like to submit a question in advance, please e-mail Trine Tsouderos at ttsouderos@tribune.com.
From the editorial page of the Wall Street Journal ...
Kathleen Spitzer
The Administration targets a drug CEO in a troubling precedent.
Health and Human Services Secretary Kathleen Sebelius made her political name in Kansas, though we wonder if she's getting special advice from Eliot Spitzer. Her department's latest attack, on the CEO of Forest Laboratories, is straight out of the former New York Attorney General's bullying playbook.
Forest Labs entered into a federal plea agreement in September over misconduct in its marketing of antidepressants Celexa and Lexapro. The allegations were among a rash of government suits claiming that marketing to doctors common among drug companies amounted to fraud against Medicare and Medicaid. The charges were odd given their implication that major companies would be dumb enough to try to hoodwink their biggest customer.
The charges also had a political flavor as an attempt to blame drug companies, rather than the fee-for-service design of the federal programs, for runaway costs. But some companies including Forest chose to settle rather than engage in extensive litigation.
In any case, the federal complaint contained no suggestion that Mr. Solomon was involved with, or even aware of, misconduct. And the question of his continued leadership was never part of the plea deal.
Only after a federal court ratified the deal in March did HHS drop its intent-to-ban bomb. Mrs. Sebelius unearthed a dusty provision in the Social Security Act that allows officials to bar executives of health companies from doing business with the government when the firms are guilty of criminal misconduct.
The feds have rarely invoked this awesome power, given the potential for coercive abuse. But Mrs. Sebelius seems bent on making it more common policy and says she can employ it even against executives who had no knowledge of an employee's misconduct. A year ago Mrs. Sebelius used it to dismiss the CEO of a small drugmaker in St. Louis.
This is a threat to every health CEO in America. If Forest wants to continue to sell its drugs to Medicare, Medicaid and the Veterans Administration—the biggest buyers of pharmaceuticals—it will have to change management. Losing the federal government as a customer is potentially crippling to a drug company.
HHS says its action is about holding corporate CEOs accountable, but it looks more like the Administration's latest bid to intimidate the health-care industry into doing its bidding on prices, regulations and political support for ObamaCare. This is the same agency that has threatened insurers with exclusion from new state-run health exchanges if they raise their premiums more than Mrs. Sebelius wants, or if they spread what she deems to be "misinformation" about the President's health bill.
The hammer on Forest Labs "reinforces everybody's worst fears—that this Administration won't do business with anybody that doesn't completely agree with its policy initiatives. Not only will it refuse to even have the argument, it will actively destroy these people," says Peter Pitts, a former Food and Drug Administration official who now runs the Center for Medicine in the Public Interest.
The precedent here is also a recipe for much more litigation. Regulators aren't above bringing flimsy cases, and corporations often settle them simply to avoid huge legal bills and additional public relations risk. If the Obama Administration intends to view every such settlement as an admission of guilt and then dictate who can run the company, you can expect a lot more litigation.
Forest Labs is sticking by Mr. Solomon, saying the exclusion is "unjustified." But even the company has acknowledged that if Mrs. Sebelius implements her ban, Mr. Solomon would be forced to step down at least temporarily while the company takes her to court. Every CEO in America will get the message that his job is at risk if he quarrels with an Administration's bureaucratic orders.
This reminds us of a similar exercise by the Justice Department against former General Re CEO Joseph Brandon. Mr. Brandon cooperated in an investigation into a 2000 reinsurance transaction between Gen Re and AIG. But the feds leaned on Warren Buffett, the chairman of Gen Re parent Berkshire Hathaway, to fire him. Mr. Buffett praised Mr. Brandon but still sacked him in 2008, though later the feds closed the case with no action against Mr. Brandon.
CEOs are accountable for their actions, but it is simply unjust for a powerful regulator like Mrs. Sebelius to threaten a company with ruin if it doesn't dismiss a CEO who has had no formal charges or proof of wrongdoing brought against him. It's another example of how this Administration views private companies as little more than agents of greed that must be made examples of when the political need arrives.
PDUFA V: Final Recommendations Fund Proposals In Two Of Three Tiers
|
BioCentury reports that, per meeting minutes released by the FDA on Thursday and Friday, the agency and industry have an agreement for PDUFA V. On the financial front, "Industry agreed to include the $65 million in additional fee revenues for drug safety in FY 2012 in the base fee revenue amount for PDUFA V.”
Next step is for the FDA to hand its draft PDUFA V recommendations to the White House for review. Then, if all goes according to plan, the agency hopes to transmit its final PDUFA V recommendations to Congress on Jan. 15, 2012.
And yet, curiously, CDER Deputy Director Doug Throckmorton (PS/one of the smartest and hardest working guys at the agency) announced that the FDA will hold a PDUFA Public Meeting in September to get more input.
Hm.
On a separate but related note, the FDA has begun a review of its regulatory operations to determine if they can be made more effective. The agency is requesting comments on whether existing rules are "outmoded, ineffective, insufficient, or excessively burdensome."
Ya think?
The review is being conducted in response to an executive order issued by President Obama in January and the deadline for comments is June 27.
So stop griping and start typing.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
