Monday, February 20, 2017

Personal Importation: It is time for Congress and the Administration to act

time for congress, president to act to support personal importation
Recently, Senators Amy Klobuchar (D-MN), Charles Grassley (R-IA) and John McCain wrote a letter to Health and Human Services(HHS) Secretary Tom Price asking him to utilize legislation crafted 14 years ago to exercise his authority to ‘enable’ personal importation of prescription medicines under provisions of the Medicare Prescription Drug Improvement and Modernization Act of 2003.

That such a request to the Secretary is necessary is a reflection of the failure of Congress to overcome the opposition of Pharma, which views personal importation as a threat to its ability to impose the highest prescription drug prices in the world upon American patients.

The Senators are not alone in making such a request. A group of 33 Democrat members of the House of Representatives sent a similar appeal to President Obama, asking him to issue an executive order shortly before the end of his Presidency. 

Also, throughout the last 14 years, advocates for personal importation have challenged previous HHS Secretaries to act on specific portions of the legislation, namely, requiring that …’The Secretary, in consultation with appropriate government agencies, shall conduct a study on the importation of drugs into the United States pursuant to section 804 of the Federal Food, Drug, and Cosmetic Act (as added by section 1121 of this Act). Not later than 12 months after the date of the enactment of this Act, the Secretary shall submit to the appropriate committees of the Congress a report providing the findings of such study”; and, “…In particular, the Secretary shall by regulation grant individuals a waiver to permit individuals to import into the United States a prescription drug that— ‘‘(A) is imported from a licensed pharmacy for personal use by an individual, not for resale, in quantities that do not exceed a 90-day supply; ‘‘(B) is accompanied by a copy of a valid prescription; ‘‘(C) is imported from Canada, from a seller registered with the Secretary; ‘‘(D) is a prescription drug approved by the Secretary under chapter V; Regulations...”.

These provisions are an early indication of the fact that there was—and remains today—a realization by Congress that even in 2003, relief was needed for the millions of Americans who were then—and today—denied access to safe, affordable brand-name prescription medicines from licensed, registered pharmacies in Tier One Countries whose standards of safety and efficacy meet or exceed those of the U.S.

Significantly, although the HHS Secretaries over the years chose to not act on the legislation, American patients acted on their own initiative, and by so doing have provided a de facto validation of the authenticity and validity of personal importation of brand-name medicines from Tier One Countries of which Canada is one.

But, rather than relying upon 14-year old legislation, it is now time for Congress to act to deal with the current state of and continuing needs of American patients to incorporate personal importation into effective legislation as reflected in the AmericanRxBillofRights which was submitted to the platform committees of the Democrat and Republican Platform Committees of the 2016 conventions.

The need for a new approach is because there exists the potential for one provision of the 2003 Act to be not only unnecessary but actually harmful to personal importation.

The provision in the 2003 act would empower the HHS Secretary to establish wholesale operations within the U.S., solely for the importation of medicines from Canada to be resold in the U.S., as well as allowing specific pharmacies to engage in personal importation.

This was opposed by many proponents of personal importation when it was first presented in the 2003 legislation.

There are several reasons for concern about this segment of the 14-year-old bill:
·       One of the debates that arose about personal importation from Canada in 2003, was a reaction from some Canadian officials being fearful that Canada would become ‘America’s drugstore’ which can be directly linked to the wholesaling provision;
·       Equally pertinent, many American advocates of personal importation believed then, and continue to do so today, that to grant such blanket authority to wholesalers and individual pharmacies would defeat the very purpose of personal importation, i.e., individual American patients’ access to safe, affordable brand-name medicines;
·       That is because we must be concerned about U.S. wholesalers gaining control over large supplies or sources of lower-cost medicines, giving them a capability to control prices in a manner similar to the abusive practices of Pharma, and crippling the ability of Americans to make purchases of their meds from any source other than the wholesalers and pharmacists.

It is time, therefore, for Congress, especially those erstwhile supporters of personal importation to come together to form a consensus on comprehensive legislation for personal importation of prescription medicines as the only readily available avenue with which to ensure that no American is denied their access to vital lifeline medicines because they are unaffordable.

This calls for consensus building in which Representatives and Senators of both parties who support personal importation instruct their staffs to come together to identify what opportunities—and obstacles—face enactment of new, current legislation to lower prescription drug prices via personal importation;  address such  problems caused by the one in ten Americans not being able to afford their medicines; to restrain the Food and Drug Administration from the seizure and destruction of medicines which can easily be identified as authentic, safe medicines.


By acting in such a manner to meet their obligations to the American public, Congress can develop legislation in which personal importation will have a major role and will reflect the realities of the needs of Americans patients today, rather than simply appealing for the HHS Secretary to carry the water on this issue.

Wednesday, February 8, 2017

HHS Pick Price Made ‘Brazen’ Stock Trades While His Committee Was Under Scrutiny

Kaiser Health News: Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation

February 7, 2017--Health and Human Services secretary nominee Tom Price showed little restraint in his personal stock trading during the three years that federal investigators were bearing down on a key House committee on which the Republican congressman served, a review of his financial disclosures shows.

Price made dozens of health industry stock trades during a three-year investigation by the Securities and Exchange Commission that focused on the Ways and Means Committee, according to financial disclosure records he filed with the House of Representatives.

The investigation was considered the first test of a law passed to ban members of Congress and their staffs from trading stock based on insider information.

Price was never a target of the federal investigation, which scrutinized a top Ways and Means staffer, and no charges were brought.

But ethics experts say Price’s personal trading, even during the thick of federal pressure on his committee, shows he was unconcerned about financial investments that could create an appearance of impropriety.

“He should have known better,” Richard Painter, former White House chief ethics attorney under President George W. Bush and a professor at the University of Minnesota Law School said of Price’s conduct during the SEC inquiry.

As Price awaits a Senate vote on his confirmation, Senate Democrats and a number of watchdog groups have asked the SEC to investigate whether Price engaged in insider trading with some of his trades in health care companies.

Price has said he abided by all ethics rules, although he acknowledged to the Senate Finance Committee that he did not consult the House Ethics Committee on trades that have now become controversial.

The SEC’s inquiry began in 2013, as it battled Ways and Means for documents to develop its case.

A few weeks ago, the day before President Donald Trump’s inauguration, the SEC quietly dropped its pursuit of committee documents without explanation, according to federal court records.

No charges were brought against the staffer, Brian Sutter, who is now a health care lobbyist. Sutter’s lawyer declined to comment.

Craig Holman, government affairs lobbyist with Public Citizen, described Price’s volume of stock trades during the SEC inquiry as “brazen,” given the congressman’s access to nonpublic information affecting the companies’ fortunes.

“The public is seeing this and they really don’t like it,” said Holman whose watchdog group recently filed complaints about Price’s stock trading with both the SEC and the Office of Congressional Ethics.

Trump administration officials and Price have dismissed questions that news reports and lawmakers have raised about stock trades coinciding with official actions to help certain companies, saying Price’s brokers chose the stocks independently and all of his conduct was transparent.

After acknowledging that he asked his broker to buy stock in an Australian drug company, he told the Senate Finance Committee that he did not direct his broker to make other trades.

“To the best of my knowledge, I have not undertaken such actions,” he wrote in response to finance committee questions. “I have abided by and adhered to all ethics and conflict of interest rules applicable to me.”

An analysis of Price’s trades shows that he bought health stocks in 2007, the first year Congress financial disclosures are posted online. In 2011, the the first year Price sat on the health subcommittee, he traded no health-related stocks, according to his financial disclosures filed with Congress.

That same year, members were facing public criticism because of a book detailing how they could use inside information and a “60 Minutes” investigation focused on how members and staff could legally use inside information to gain from their own stock trades.

In 2012, President Barack Obama signed the Stop Trading on Congressional Knowledge Act to rein in insider trading by members and require more disclosure. Public watchdog groups suggested at the time that the law would curb the practice.

That year, after his one-year break in health care trades, Price resumed investing in health care companies.

Along with investments in technology, financial services and retail stocks, he also bought and sold stock in companies that could be impacted by actions of his subcommittee, which has a role in determining rates the government pays under the Medicare program.

Health care firms spend heavily to influence members of Congress, lobbying on health matters, funding political campaigns and seeking favor with Medicare officials who decide how much the program will pay for certain drugs and devices. The Food and Drug Administration holds similar power, approving or putting conditions on drug and device use.

Beyond his personal investments in health care companies, Price has also advocated their interests in letters to officials and proposed laws, government records show.

In 2012, disclosure records show Price sold stock in several drug firms, including more than $110,000 worth of Amgen stock. Amgen’s stock price had steadily climbed out of a recession-level slump, but Price’s sale came a few weeks before the company pleaded guilty to illegally marketing an anemia drug.

By 2013, the health subcommittee was at the center of a major conflict between Medicare, which sets Medicare Advantage rates, and the insurance industry.

Medicare issued a notice early that year announcing its intention to reduce Medicare Advantage rates by 2.3 percent as part of a major cost-cutting initiative.

That prompted fierce lobbying by the health insurance industry. Members of Congress, including Price, wrote a letter to Marilyn Tavenner, then acting administrator for the Centers for Medicare & Medicaid Services, protesting the rate cut, saying the decrease would “disadvantage vulnerable beneficiaries with multiple chronic conditions.”

Ultimately, Medicare decided not to cut rates but instead, to increase them. Yet an hour before Medicare announced the change, a Height Securities analyst fired off a “flash” report to 200 clients that touched off a surge of trading.

The analyst’s report said a political deal was hatched on Capitol Hill to prevent the cuts as a condition for moving forward on Tavenner’s confirmation. Medicare officials increased rates by nearly 4 percent, a change that would positively impact the bottom lines of health insurance companies.

The SEC began looking for the leak’s source, and within weeks, FBI agents began interviewing staffers at the Ways and Means Committee, court records show.

They discovered communications between Sutter and a health care lobbyist. The HHS Inspector General also began a probe, and federal prosecutors briefly examined the matter activity as well.

As the case unfolded, Price bought more health care-related stocks, according to his financial disclosures.

He has testified that his broker directed all of the trades, except for his investments in Innate Immunotherapeutics, an Australian company partly owned by Rep. Chris Collins (R-N.Y.), according to Collins’ disclosures. An HHS spokesman said Monday that Price held three broker-directed accounts.

Ethics experts have said that Price should have further distanced himself by placing his assets in a blind trust.

On April 30, 2013, Price bought $2,093 worth of stocks in Incyte, a company that develops cancer drugs; $2,076 in Onyx Pharmaceuticals, a drugmaker that would soon merge with a larger drug firm; and $2,097 in Parexel International, a consultancy that helps drugs and devices win FDA approval, according to the financial disclosure records.

The same day, Price shed shares of Express Scripts, a drug management firm, and Danaher, which makes products hospitals and doctor’s offices using for testing and diagnostics. In August of that year, he bought a $2,429 stake in Jazz Pharmaceuticals, which makes sleep and cancer drugs.

On May 6, 2014, the SEC served its first subpoena for the Ways and Means Committee documents. The committee launched a vigorous fight, appealing a federal district judge’s ruling that it should comply with the SEC subpoena.

Price continued his health stock trades, including $1,000 to $15,000 in drug firms Amgen, Eli Lilly and Co., Pfizer, Biogen and Bristol-Myers Squibb.

He also bought stocks in Aetna, a major health insurer, and Athenahealth, which sells electronic medical record and medical billing software. In 2016, he also increased his investment in Innate Immunotherapeutics.

The purchase became controversial because both he and Collins bought stock in a private placement at a discounted price.

“You’re asking for trouble if you have access to nonpublic information about the health care industry and you’re buying and selling health care stocks,” Painter said.

Monday, February 6, 2017

Sanders: Will Trump Really Take on Pharmaceutical Industry? I Hope So



Senator Sanders to introduce bill to lower prescription drug costs
Senator Bernie Sanders
Sanders-Cummings legislation to incorporate personal importation

WASHINGTON, February 4, 2017-- Sen. Bernie Sanders (I-Vt.) says he will soon introduce legislation to lower prescription drug prices and hoped that President Donald Trump would support the effort.

Sanders and Rep. Elijah E. Cummings (D-Md.) are drafting legislation to significantly bring down drug prices in the United States.

While five major drug manufacturers made more than $50 billion in profits in 2015, nearly 1 in 5 Americans could not afford the medicine they were prescribed at a time when Americans pay, by far, the highest prices in the world for prescription medicine. 

Representative Cummings
“It is beyond comprehension that while Americans are dying because they cannot afford the medications they need, the 10 highest-paid CEOs in the pharmaceutical industry collectively made $327 million in 2015,” Sanders said.

“I look forward to working with President Trump on this issue if he is serious about standing up to the pharmaceutical industry and reducing drug prices,” Sanders said after Trump met with chief executives of several top drugmakers at the White House Tuesday.

The Sanders and Cummings proposal would allow Medicare, the health care program for seniors and people with disabilities, to negotiate with drugmakers for lower prices. “The root of this problem is that we are the only major country not to negotiate drug prices with the pharmaceutical industry. You can walk into a pharmacy today and the price could be double or even three times what you paid for the same medicine a year ago,” Sanders said.

Their legislation also would allow the importation of less expensive but safe and affordable drugs from other countries. The allergy treatment EpiPen, for example, costs $638 in the U.S. compared to $293 in Canada. A popular drug for high cholesterol, Crestor, costs $779 in the U.S. but $201 in Canada. Abilify, a depression medication, costs $2,852 for a 90-day supply in the U.S. but only $546 in Canada.