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Senior Citizen Politics
Pharmaceutical Company Misdeeds Being Exposed in
Washington
Pricing problems, failure to do promised studies
found, Dems want more regulation
 February 2, 2007 – As might have been expected, the
scrutiny of pharmaceutical companies is escalating with a Democratic
congress. A senate committee has found pricing irregularities in
Medicaid, the FDA finds they have not begun 71% of post-approval studies
that were promised as a condition of
FDA
approval of a drug, and Democrats have introduced legislation to require
increased prescription drug regulation by the FDA.
 Senate
Committee Investigation Finds Pharmaceutical Companies Improperly Used
Exception in Medicaid Drug Rebate Program
Some pharmaceutical companies have improperly used
a "nominal price exception" to reduce rebates that states receive as
part of the Medicaid Drug Rebate Program, according to the results of a
three-year
Senate Finance
Committee investigation released on Thursday, CQ HealthBeat
reports.
Under the program, pharmaceutical companies must
report to the federal government the lowest price at which they sold
medications to any U.S. purchaser. However, "Congress created an
exception to best-price reporting to encourage drug companies to
continue making drugs available to charitable organizations at prices
below market rates," CQ HealthBeat reports.
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Senate Bill to Stop Pay-Offs that Delay Generic
Drugs Coming to Market
Key sponsor is Herb Kohl, new chair of Special
Committee on Aging
January 26, 2007 – A practice that has long
aggravated many senior citizens, struggling to pay for the prescription
drugs they need, may soon come to an end. A bill to "explicitly" prohibit
brand-name drug manufacturers from using pay-off agreements to keep less
expensive generic equivalents off the market was announced in the senate
by the new chairman of the Special Committee on Aging, Herb Kohl (D-WI).
Read more...
Medicare, Medicaid May Save $70 Billion in New Bush
Budget Proposal
'He still acts as if Republicans were in complete
control and Democrats had lost the election,' Sen. Rangel (D-N.Y.)
 February 2, 2007 – President Bush is expected to
unveil his plan next week for balancing the budget and over $70 billion
of the savings are expected to come from Medicare and Medicaid, two
programs of critical importance to most senior citizens. Higher Medicare
premiums for higher income seniors and holding back on the fees paid to
home health agencies, hospitals, nursing homes and other health care
providers are expected to produce most of the savings, according to the
New York Times. Democrats are not welcoming these ideas, finds
KaiserNetwork.org.
Read more...
Read more
on
Politics for Senior Citizens |
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In April 2004, committee Chair Max Baucus (D-Mont.)
and ranking member Chuck Grassley (R-Iowa) began an investigation into
whether pharmaceutical companies had improperly used the exception. The
investigation sought information from 19 pharmaceutical companies on
their use of the exception.
In a Jan. 31 letter sent from Baucus and Grassley
to acting
CMS
Administrator Leslie Norwalk, the senators wrote that the investigation
found:
● Most pharmaceutical companies did not comply
with congressional intent in their use of the exception;
● The policies of most pharmaceutical companies
did not indicate use of the exception for charitable purposes;
● Most pharmaceutical companies used the
exception for medications in the classes of treatments with the highest
sales;
● Pharmaceutical companies in most cases did not
consider charitable purposes when they sold medications at nominal
prices; and
● Pharmaceutical companies in most cases sold
medications at nominal prices to hospitals.
The fiscal year 2006 budget reconciliation law
enacted in February 2006 sought to address improper use of the exception
by pharmaceutical companies, and CMS last month proposed a rule to
implement the law.
Baucus in a statement said, "The law that closes
the nominal pricing loophole must be implemented fully to make sure
Medicaid works as well as it can for beneficiaries and for every
American taxpayer."
Grassley said that implementation of the law will
ensure "there's no more opportunity for the kind of 'interpretation'
that was going on by drug companies who were using this loophole as a
marketing ploy."
CMS spokesperson Jeff Nelligan said that, because
the rule "is currently open for public comment, it would not be
appropriate to comment publicly on the letter" but added that "we
welcome and will consider all public comment in developing the final
rule" (Carey, CQ HealthBeat, 2/1).
Prescription
Drug Makers Have Not Begun Many Pending Post-Market Studies on Newly
Approved Drugs, FDA Says
Prescription drug companies as of Sept. 30, 2006,
have not begun 71% of post-approval studies that were promised as a
condition of
FDA
approval of a drug, according to an annual FDA report released on
Thursday,
Bloomberg/Long
Island Newsday reports.
Drug makers often agree to conduct post-market
studies of safety, dosage and other factors of a drug to receive FDA
approval. According to the agency, 899 of 1,259 pending post-approval
studies have not been started (Bloomberg/Long Island Newsday, 2/2).
FDA found that of the post-approval studies that
had been initiated, 184 were on or ahead of schedule, 144 had been
submitted for FDA review or terminated, and 31 were labeled as
"delayed." The FDA report did not indicate the number of drugs covered
by the studies, as some drugs require multiple studies.
In addition, the report did not specify over what
time period the studies had been requested. Not all of the uninitiated
studies were considered late by the agency, because drug companies and
FDA can spend months discussing study design (Bloomberg/Los
Angeles Times, 2/2).
Post-approval studies usually are voluntary, so FDA
cannot impose fines or penalties on drug companies who do not conduct
the studies.
Bill Vaughan, senior policy analyst with
Consumers Union,
asked, "How can the FDA claim it is committed to improving drug safety
when it can't even get drug makers to do the studies they promise?
Should consumers really feel safe when two out of three studies aren't
being done, and the FDA doesn't even have the authority to get them
done?"
FDA spokesperson Susan Cruzan said the agency is
working to improve its ability to track and monitor post-approval
studies and is looking to work with drug makers to complete the studies.
Alan Goldhammer, deputy vice president for
regulatory affairs at the
Pharmaceutical
Research and Manufacturers of America, said that drug
companies are committed to finishing post-approval studies but sometimes
have difficulty finding study participants (Bloomberg/Long Island
Newsday, 2/2).
Democratic
Lawmakers Introduce Legislation to Reform FDA, Increase Prescription
Drug Regulation
Democratic lawmakers this week introduced bills
that would reform
FDA
and boost regulation of prescription drugs, the Wall Street Journal
reports. On Thursday, Sens. Edward Kennedy (D-Mass.) and Michael Enzi
(R-Wyo.) introduced a bill (S
484) that would boost FDA's oversight authority by requiring
drug approvals to be paired with programs to manage risk once they reach
the market.
These programs could include mandatory post-market
safety studies, restrictions on which providers can prescribe or
dispense a drug or a moratorium on direct-to-consumer advertising for
newly-approved drugs.
The Kennedy-Enzi bill also would require all
clinical trials to be registered and their results stored in a public
database. Rep. Henry Waxman (D-Calif.) has said he plans to introduce a
drug safety bill similar to the Kennedy-Enzi bill in the House.
Waxman also plans to introduce legislation that
would allow generic versions of biotech drugs, which would provide
significant competition for the costly brand-name versions of the drugs.
Meanwhile, Sens. Chris Dodd (D-Conn.) and Charles
Grassley (R-Iowa) on Wednesday introduced legislation (S
467) that would restructure FDA to create a center to oversee
drug safety post-approval. The Journal notes that a "ready-made vehicle"
for changes in drug regulation and FDA authority is the user-fee
agreement between drug companies and the agency, which provides much of
the funding for FDA's drug-review process. The user-fee agreement --
under which drug companies pay fees to FDA in exchange for quicker
reviews of new drug applications -- expires this year.
Comments
Lawmakers are not in agreement over whether regulatory legislation
should be linked with the user-fee agreement, according to the Journal.
Rep. John Dingell (D-Mich.), chair of the
House Energy and
Commerce Committee -- which has jurisdiction over the FDA --
said he does not want to "bog down" the user-fee bill with additional
provisions. If Congress does not pass the user-fee renewal by late
summer, "it risks shutting down much of the agency's drug-regulation
activity," the Journal reports.
FDA in January
announced
that it was able to negotiate with the pharmaceutical industry for $393
million in fees for the next fiscal year -- an increase of about
one-third over current levels. The increase "would grant the FDA
substantially more money for safety monitoring and fund more staff to
review pharmaceutical ads," according to the Journal (Wilde Mathews,
Wall Street Journal, 2/2).
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