> CONGRESS & THE PRESIDENCYWith the clear victory of Sen. Barack Obama (D-IL) over Sen. John McCain (R-AZ) in the Presidential race, after a campaign that lasted just shy of two whole years, the voters have indicated the need for a revolutionary change in America. Change from a White House philosophy which has a) had us committed abroad in an expensive war seeming without end, b) has more than tripled the National Debt, and c) has provided tax incentives to business that we saw turned into sinfully excessive salaries for executives …  and layoffs for the rank and file.

. The House Democratic majority is now much more clearly established than in the last two years; the Senate finally has a clear Democratic majority, as opposed to the razor-thin edge it has held recently.  Thus hopes are high for increasing funding for many social programs that have been cut or held level for years.  To provide these increases will require new revenue, particularly given the expense of the bailout(s). Hopefully a large down payment on this can come from winding down the war in Iraq and letting Bush tax cuts for business expire. more...

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> STATE-LEVEL ISSUES

.On September 18^th, the California Legislature and Governor came together, more than two months after the state’s fiscal year had begun, and agreed to an amount for the 2008-2009 Fiscal Year Budget that all parties were willing to accept. Since over four and a quarter Billion dollars in state expenditures – for health care, education, food and other programs – was held up over this two month period, causing severe hardships on those most in need across the state, pressure was extreme to resolve the matter so checks could flow. The compromise budget creates no new taxes; it does however borrow funds, mostly from future years, to close the current deficit. Savings found also come through increased penalties for corporations late in filing taxes in excess of $1 Million, and in unspecified line-item vetoes by the Governor in months to come.   An estimated $7 Billion additional deficit will be accrued between now and next August 30 when Fiscal Year 2009 ends, so these battles are not over. In terms of specific programs of near-term importance to the hemophilia community, the 10% across-the-board budget cut will be implemented at once in state programs such as the Genetically Handicapped Persons Program (GHPP) which serves many persons with hemophilia.  It will not be implemented in Medi-Cal (Medicaid) payments to pharmacies, due to a court injunction.  Next March 1, the cuts in state-only programs like GHPP will be reduced from 10% to 1%, and cuts in Medi-Cal payments will begin, but only at a 5% level. more...

> STATE –LEVEL ISSUES

As we approach the end of summer and the final election run, the serious economic situation in the country does not appear to have yet hit bottom. As we have reported, according to the Center for Budget & Policy Priorities, 27 states face serious deficits totaling almost $50 billion this year; California’s deficit, the largest, equals roughly one-third of this amount. As the national economy deteriorates, incomes fall and less taxes are paid; state revenues are reduced accordingly.

For chronic disease communities such as hemophilia the situation is rapidly going from bad to worse. Expensive chronic diseases are on the radar screen of those states facing serious deficits. Local hemophilia organizations and the three national organizations, COTT, NHF and HFA, are all spending a greater degree of time and resources putting out fires in places like Sacramento, California; Austin, Texas; and Frankfort, Kentucky as well as elsewhere. In all of these capitals the story is similar: a relatively small number of state-assisted chronic disease clients are found to have been spending a comparatively inordinate amount of a given state’s available health care dollars. Therefore states immediately look at hemophilia treatment and care as a line item that certainly must be adjusted downward to save critical dollars. No medical decision-making is involved when this is then done. For chronic disease communities, the impact of these cuts is substantial and for some chronic diseases communities catastrophic.  more...

.> STATE-LEVEL ISSUES

.The California Legislature continues to grapple with the Governor’s proposed across-the-board cuts for the fiscal year which has just begun (as of July 1). The Legislature acceded to the Governor’s requests in the spirit of looming crisis and enacted these cuts in February, shortly after they were proposed. Much work has ensued between then and this month to modify them substantially.  It appears that the will has been expressed, in both chambers and across both parties, to seek a moderation of the cuts, although some debate persists as to the source of the revenues to make up the savings if certain programs are not cut.  COTT continues to work closely with the Hemophilia Council of California as matters proceed over the summer.  COTT President Corey Dubin has been appointed to the Advocacy Committee of the Southern California Hemophilia Foundation, known as SoCal, earlier this month. This presents broadened opportunities for coordination between COTT and local, grass-roots organizations as the budget crisis unfolds. more...

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> STATE-LEVEL ISSUES.

In California, draconian budget cuts resulting from a 2 year 20 billion dollar deficit for fiscal years 2008 and 2009 has resulted in the Governor calling for 10% across the board cut in state program reimbursement for health care services.  Starting July 1, these cuts will result in a 10% cut in reimbursement for factor concentrates for those enrolled in state-funded programs. This is likely to create a significant, and in some cases unworkable situation for many of the home care providers and Hemophilia Treatment Centers who deliver factor concentrates and associated services to the hemophilia/bleeding disorders community. For some chronic disease communities, such as pulmonary hypertension, these cuts will result in a serious interruption in access to care. In our community the cuts certainly will impact both access to care and the quality of that care. As we go to press the California Senate Budget Committee will meet to consider the cuts and the Budget Legislation that is the roadmap for the budget. Meanwhile the Assembly continues to oppose the cuts in health care. The entire budget debate in Sacramento is even more convoluted on the revenue side of the equation as State law mandates a two-thirds vote in the Legislature to raise revenues through new taxes. This rule allows the Republican minority to block any revenue-raising proposal, even those emanating from the Republican Governor, leaving only program cuts as a means to reduce the deficit. However, across the board cuts, including health in with all other state functions, clearly is the most damaging plan. more...

> CONGRESS

GINA, the Genetic Information Nondiscrimination Act, was signed into law May 21^st by the President, ending a harrowing three years of being bounced between the chambers of Congress and then stalled last year and this, only to emerge to the surprise of many and sail through approval.  The bill prohibits discrimination through use of genetic testing in health insurance and in employment. more...

> Congress

Recoiling from the Proposed Fiscal Year 2009 Budget sent to the Hill by the President in late February, yet burned by the memory from last December of his rigid refusal to sign any funding bill that went over his targets, the two chambers began their annual process to develop their own Budget documents in March, necessary before Appropriations bills can be developed.  Ideological lines do not seem to be drawn in the same way as last year, when the two sides of the Hill could not agree on a single Budget (and therefore were less equipped to resist efforts to exceed targets).  Instead this year’s Economic Stimulus Package of several hundred billion, the enormity of the expenditures for US actions in Iraq and Afghanistan, and the rising profile of the Presidential election have had their attention. Oh and of course major league baseball drug use.

Recently enacted cuts in California state health and other programs threaten access to care for those dependent on Medicaid and other state programs. The governor proposed in February an across-the-board 10% cut in all areas of the state budget, effective with the beginning of the new fiscal year July 1. Using the threat of a possible downgrade in the state’s bond ratings from Wall Street, he persuaded the legislature to quickly approve his proposal with few modifications. COTT has been assisting in the substantial efforts now going on in the state to urge Legislators to reconsider these cuts, both in their severity and in their blind application across even programs dealing with life-threatening situations. We have given testimony before the State Legislature's Health Committee in Sacramento, and met with several key Budget Committee offices.

More advocacy work will be needed to achieve success at giving the legislators the commitment to undo their rushed consent to the Governor's proposed cuts. Any such cuts must be targeted in a way that exempts services to health communities like ours.

Key legislators tell us that for the most part members of both the Governor's party and the Majority party are by now well aware of the dire implications of the cuts, but need to see evidence from their home district constituencies of public outcry against these threatened services reductions before they can take the strong stands needed to undo what has been approved and block further cuts. Californians: Mobilize!! your resources for visible, local statements (op-ed, etc.) and events (rallies or speeches at other events, with media). Contact Legislators using this link to register  your concerns and, particularly, convey how these cuts would affect you.  COTT is working closely with the Hemophilia Council of California (510-234-8655) on this campaign; contact either organization for more information. COTT is next due to speak to community members on this at the Advocacy Day being held by the Hemophilia Association of SoCal (888-371-4123) later this month in Los Angeles.

Special Note for those outside of California: The California Medicaid program (Medi-Cal) serves one-fifth of all Medicaid clients in the country. Other states' Medicaid programs are also in fiscal crisis.  If California’s cuts are the deepest, that will quickly become the norm across the land.

Contacting Legislators: more...

> CONGRESS

Congress spent much of the first month of the Second Session of the 110^th Congress (that is, January) in meetings and party-member retreats, as is customary.  Back on the Hill, machinery was oiled to prepare to push this year selected major bills from last year that did not pass. But one legislative issue dominated the month: the Economic Stimulus Package, a $146 billion response to the sagging US economy triggered by widespread mortgage foreclosures. Signed into law February 13^th after three or more weeks of very public negotiations with the White House, it provides tax rebates of several hundred dollars to all filers; expands the Federal Housing Administration (FHA) loan program through raising the ceiling on the amount that can be financed;  and permits accelerated depreciation for business owners. more...

> CONGRESS

Aprropriations (funding): Democratic leaders, having a hard time tearing their attention away from the first of the primaries now  under way, find themselves both reeling from the ragged, humbling end of the FY08 appropriations struggle last month, and at the same time trying to forge (with little apparent success) a strategy for the same matters this year.  The President has gone on record recently saying that this year will be conducted with the same rigidity from his side – vetoing any spending bill in the fall that exceeds the budget he lays down in the spring, to be released February 5. (CQToday of 1/14: “Bush vows to hold the line again on taxes and spending.”) As a result, even though it looks to all like the next President will be a Democrat, with different budget priorities tha we have seen from the White House these last seven years, that begins with inauguration – which is in 2009, not in time to help with this year’s budget fights. more...

The Update adds three new features with this issue, located at the end of the current format. These include: a regular section on COTT Operations; a Blood Safety Summary drawing from the articles; and an Errata listing.                                                                    .

> INTERNATIONAL

- JapanThe judge overseeing last spring’s huge settlement between the HCV-infected hemophilia community and fractionators and the government this month recommended the two parties negotiate a settlement.  Since all are agreed on the general size range of the settlement, albeit not as great as the initial award would have been, Judge Katsutoshi Yokota suggested that negotiation, overseen by the court, is the best way to resolve remaining differences – which include the scope of the compensation, and that the companies offer formal apology. more...

November 29, 2007

An Open Letter to the Manufacturers of Clotting Factor Products and the Government Agencies who Regulate Them:

Individuals affected by bleeding disorders depend on the availability of safe and efficacious clotting factor concentrates for their very lives. In the 1980s, the community was ravaged by the proliferation of HIV/AIDS and HCV tainted plasma derivatives. Many lessons were learned during that period about the importance of vigilance, and today we are fortunate to have an adequate supply of safe products, both recombinant and plasma-derived. However, recent events have created the perception that vigilance has started to wane. more...

Las miles de personas con la afección coagularse de hemofilia quiénes viven en cinco estados están siendo dicho que ellos ya no puedan comprar su medicina por medio de su farmacia actual – por lo general enviandola a la casa al debido del costo y exigencias de refrigeración – y en cambio dijeron que todos/as deben usar una nueva farmacia, del dueño que se llama “Cruz Azul” o “Blue Cross.” Los estados son Indiana, Kentucky, Missouri, Ohio, y Wisconsin. more...

“If it ain’t broke, don’t fix it”

Thousands of people with the clotting disorder hemophilia who live in five states are being told they can no longer purchase their medicine through their current pharmacy – usually having it shipped to the home due to cost and refrigeration requirements – and instead told they must use a new pharmacy, owned by their insurer, Blue Cross. The states are Indiana, Kentucky, Missouri, Ohio, and Wisconsin.

> INTERNATIONAL

In a decision that shocked the Canadian hemophilia community, Ontario provincial Superior Court Justice Mary Lou Benotto concluded that that 3 Canadian doctors, US drug company, Armour Pharmaceutical and one of it’s former vice-presidents, Dr. Michael Rodell, were not guilty of negligence in the HIV infection of over 1000 Canadian persons with hemophilia through tainted blood products. Justice Benotto, announced the verdict to a packed courthouse on September 28^th. Members of the Canadian Hemophilia Society present in the courtroom were visibly shaken as the Justice spoke. more...

> CONGRESS

Since the last COTT Washington Update, published June 8, Congress has wrestled, with little success, with several large-scope authorization issues, while attempting to work through the annual set of appropriations bills simultaneously. Examples of the former include renewal of the major energy and farm bills, and, more recently, the Genetic Information Nondiscrimination Act (GINA) and the State Childrens’ Health Insurance Program (SCHIP).  Neither of the last two, both important to the hemophilia community, succeeded in obtaining passage before Congress adjourned for its month-long Summer Recess last week.

The House of Representatives on July 11^th passed its version of legislation to re-authorize the Prescription Drug User Fee Act (PDUFA), which since 1992 has permitted the drug industry to pay FDA for FDA’s reviews of industry applications for new drug licenses. That’s right, the regulated industry pays the federal regulators for regulating the safety of the drugs the industry then sells us. more...

> CONGRESS

Congress occupied itself in the last month with development of a War Supplemental bill to replace the one vetoed by the President; with forging a new immigration House-Senate compromise, although at this writing success is not assured; and with one more attempt to agree on a House-Senate FY2008 Budget Resolution, which succeeded on May 17^th. Appropriations hearings are in high gear; first subcommittee bills are expected shortly.  more...

Ten days ago, COTT had delivered to the offices of the American Thrombosis and Hemostasis Network (ATHN) a Memo posing questions left in our mind after the ATHN presentations we attended in February and March.  Ranging from narrow to broad, we believe that many of these questions are the same that most of the hemophilia community is asking.  Perhaps key among other things, we’re asking how ATHN and its creators propose to collect data from our health records at our HTCs – and then sell those health records to private corporations for their purposes, and perhaps for further resale. more...

> CONGRESS

When this Update began publication in 1998, we were at the height of the efforts to get Ricky Ray passed and then funded.  Nearly every issue had specific requests for you to engage in political action.  Time has passed since then, but this spring so much is possible and so much is being attempted that we call on the community again to be ready to act.  We will provide specifics as needed.

There are multiple bills affecting FDA which are likely to pass this year. The two biggest are two of the three FDA bills COTT is concerned with. One of these, labeled FDA Reform, is for changes in FDA’s drug review process, and substantially increased programs for monitoring of post-market problems, findings and of television advertising. The other is the renewal of the Prescription Drug User Fee Act (PDUFA), for the third time allowing industry to pay FDA for review of its candidate drugs.  Committee action on PDUFA took place April 18 in the Senate; a date has not been set in the House although a four-hour hearing on PDUFA was held there April 17^th. more...

> CONGRESS

Congress heads into its first two week recess of the year. Republican entrenchment, triggered by the new Democratic majority’s “100 hours” in the House in January (during which no Republican amendments were heard), grew in February and became a force to be reckoned with in March.  Four major money bills demonstrate this. more...

> CONGRESS

 COTT is pursuing seven legislative agendas this spring, all with implications for agency regulatory policy once enacted. The first three concern FDA: 

1) Make consumer participation on all FDA Advisory Committees mandatory.  Of 47 committees, many have an industry representative but no consumer representative. 

2) Block renewal of the Prescription Drug User Fee Act, which since 1994 has permitted drug companies to pay FDA for reviewing applications from the companies for new products. 

3) Restructure FDA New Drug Review and oversight functions, placing the Office of New Drugs where its voice can be heard vs. its present situation within the New Drug office, which repeatedly has ignored its safety findings. Empowering much stronger oversight on drugs once approved, and on advertising.

 4) MediGap – enact the language COTT and others have developed to help with the costs of Medicare co-payments of twenty percent – impossible when drugs cost $20,000/month. 

5) Mad Cow – work for more realistic USDA sampling of the American herd, not the whitewash to date; press FDA to base its reporting on risk to the blood supply on sound risk estimates. 

6) Hepatitis Care – work for the passage of the Hepatitis Epidemic Control Act, introduced in May of 2003 by Senators Kennedy and Hutchison but never considered even for a hearing in four years’ time. (Hepatitis Compensation remains on COTT’s list, awaiting optimum conditions.) 

7) HTC Funding – Identify areas in the HTC 340b program in need of rectification to comply with federal law, such as use of profit funds, out-of-area marketing, and offering true choice to consumers.  Explore alternative federal support strategies for current 340b HTCs. more...

> CONGRESS

Having decided that staying in session another week closer to Christmas would not permit passage of pending appropriations bills nor provide a chance to raise support for any of the many remaining Republican initiatives remaining unfulfilled, Congress has adjourned, terminating the 109^th two-year “Congress” (session) in the pre-dawn hours of December 9^th. 

We are pleased to report, in one of the largest cliff-hangers in the health community, that the Ryan White CARE Act, in place since 1990 and overdue for its periodic renewal, was one of the last votes taken as the House closed down.  The new law, which must itself be renewed in three years rather than the normal five, makes major changes in the way AIDS programs operate.  more...

> CONGRESS

Exceeding nervous Democrats’ expectations, the results of the 2006 Mid-Term Congressional elections gave that party control of the House by 34 seats vs. the 29-seat control the Republican party has enjoyed the last two years, a sixty-three-seat change in party.  After a several-days cliffhanger over one particular race (VA), Democrats won control of the Senate as well (by one vote only, however). more...

> CONGRESS

Since our September-October Washington Update was published October 6, Congress has not been in session (except for the newly reconstituted and refurbished House Ethics Committee, which has already spent days and days hearing testimony from those involved, however peripherally, in the Mark Foley scandal).   What HAS been going on during this time is a steady and perhaps accelerating shift in the public’s support of the Administration.  Between 10/15 and 10/20, results of three national polls were released, showing almost the same results: NBC reported the following: more...