[e-drug] United States Congress Investigates Drug Price Increases for Generic Drugs

E-DRUG: United States Congress Investigates Drug Price Increases for Generic Drugs
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Dear E-druggers,
The United States Congress is investigating the staggering price increase
of certain generic drugs. According to data provided the price of one
commonly used antibiotic doxycycline [in USA] has jumped from US$ 20.00 (bottle of
500 tablets of 100mg strength) in October 2013 to US$ 1849.00 in April
2014. According to the letter to the drug companies, generic drugs play a
major role in the U.S., accounting for about 29% of the pharmaceutical
spending and 86% of dispensing. The results of this investigation is
likely to result in increased public debate on this topic and strategies to
reduce drug prices. I thought this topic may be of interest to all parties
in this forum especially those who are working on access to medicines and
pricing issues.

Thanks,

Rizwan

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Oct 2, 2014
Press Release
Letters to 14 Manufacturers Seek Information on Recent Price Hikes

Washington, D.C. Today, Rep. Elijah E. Cummings, Ranking Member of the
House Committee on Oversight and Government Reform, and Senator Bernard
Sanders, Chairman of the Subcommittee on Primary Health and Aging, Senate
Committee on Health, Education, Labor and Pensions, sent letters to 14 drug
manufacturers requesting information about the escalating prices they have
been charging for generic drugs.

Cummings and Sanders are investigating price increases for drugs used to
treat everything from common medical conditions to life-threatening
illnesses and to identify measures to help reduce costs for patients,
healthcare providers, and hospitals across the country.

'When you see how much the prices of these drugs have increased just over
the past year, it's staggering, and we want to know why,' said Cummings. 'I
am very pleased that Chairman Sanders has joined me in this bicameral
investigation because in some cases these outrageous price hikes are
preventing patients from getting the drugs they need.'

'It is unacceptable that Americans pay, by far, the highest prices in the
world for prescription drugs,' Sanders said. 'Generic drugs were meant to
help make medications affordable for the millions of Americans who rely on
prescriptions to manage their health needs. We've got to get to the bottom
of these enormous price increases.'

In their letters, Cummings and Sanders cited data from the Healthcare
Supply Chain Association on recent purchases of 10 generic drugs by group
purchasing organizations over the past two years. For example:

   - Albuterol Sulfate, used to treat asthma and other lung conditions,
   increased 4,014% for a bottle of 100 2 mg tablets.
   - Doxycycline Hyclate, an antibiotic used to treat a variety of
   infections, increased 8,281% for a bottle of 500 100 mg tablets.
   - Glycopyrrolate, used to prevent irregular heartbeats during surgery,
   increased 2,728% for a box of 10 0.2 mg/mL, 20 mL vials.

Click *here
http://tinyurl.com/p4bzonh
for
a table of price increases for the ten drugs examined.

The Members also explained that these dramatic price increases result in
decreased access for patients and increased costs to American taxpayers.

A *survey <https://www.ncpanet.org/pdf/leg/jan14/letter-generic-spikes.pdf&gt;\* by
the National Community Pharmacists Association found that 77% of
pharmacists reported 26 or more instances over the past six months of a
large upswing in a generic drug's acquisition price, and pharmacists also
reported that patients are 'declining their medication due to increased
co-pays.'

According to a *report
<http://tinyurl.com/oyn568n&gt;\*
by
the IMS Institute for Health Informatics, generic drugs now account for 29
percent of pharmaceutical spending and 86 percent of drugs dispensed in the
United States.

The Members requested that the companies provide information from 2012 to
the present, including total gross revenues from sales of the drugs, prices
paid for the drugs, factors that contributed to decisions to increase
prices, and the identity of company officials responsible for setting drug
prices.

Letters to the 14 drug manufactures are linked below:
*Actavis plc
<http://tinyurl.com/ptxq6zz&gt;\*
*Apotex Corp.
<http://tinyurl.com/oytmcgz&gt;\*
*Dr. Reddy's Laboratories Ltd.
<http://tinyurl.com/nhgroztf&gt;\*
*Endo International plc
<http://tinyurl.com/p9p23yp&gt;\*
*Global Pharmaceuticals
<http://tinyurl.com/p9xa3du&gt;\*
*Heritage Pharmaceuticals Inc.
<http://tinyurl.com/o4vu97h&gt;\*
*Lannett Company, Inc.
<http://tinyurl.com/pw3y39h&gt;\*
*Marathon Pharmaceuticals, LLC
<http://tinyurl.com/p7cqr6j&gt;\*
*Mylan Inc.
<http://tinyurl.com/onpkbpq&gt;\*
*PAR Pharmaceutical Companies Inc.
<http://tinyurl.com/mav3svt&gt;\*
*Sun Pharmaceutical Industries, Inc.
<http://tinyurl.com/qhv97t3&gt;\*
*Teva Pharmaceutical Industries Ltd.
<http://tinyurl.com/pqxwhou&gt;\*
*West-Ward Pharmaceutical Corp.
<http://tinyurl.com/kzc9cul&gt;\*
*Zydus Pharmaceuticals USA Inc.
<http://tinyurl.com/qz74xmd&gt;\*
--------
Syed Rizwanuddin Ahmad, MD, MPH, FISPE, FCP
Consultant with Special Interest to Strengthen National Medicines
Regulatory Authorities in Resource-limited Countries
Formerly (1998-2013) with the U.S. Food and Drug Administration
Assistant Professor (adjunct), Georgetown University School of Medicine,
Washington, DC, USA
www.drugsafetyconsultant.com
Email: drugsafetyconsultant@gmail.com

E-DRUG: United States Congress Investigates Drug Price Increase for Generic Drugs (2)
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The problem with the requests that are being made to the manufacturers is that the Congress is asking for list prices which are hardly ever real prices. They may be the prices paid by individuals without health insurance and who do not know better but the reality worldwide is that list prices are a starting point for price reductions. Prices are reduced by discounts which occur before invoicing. These may be up to 97% in the case of originator medicines offered to hospitals that will start a patient on a medicine as an inpatient and then will continue lifelong. Then there are rebates which occur after invoicing and often are based on revenue paid for multiple products from the same company or wholesaler. The final method is bundling in which the deal is buy three and get one free. Or this can be complicated by offering a deal of buy three and get five of another product (not ordered) free. In this circumstance it is very difficult for the purchaser to calculate the true price of the three because they would need to value the five they did not want and may struggle to sell.

So what are real drug prices? The easiest prices to ascertain are tender prices for large scale procurement. For these prices there are no discounts, rebates or bundling. Prices may be affected by volume but are often most affected by the reliability of the purchaser in paying their bills. Internationally these prices are reported in the MSH International Drug Price Indicator Guide (http://erc.msh.org/mainpage.cfm?file=1.0.htm&module=DMP&language=English) but there are many similar reports from Europe and in the US Department of Veterans Affairs.

Of interest to the example used is that the MSH International Reference Price for doxycycline 100mg is a median price of $0.0144/tab-cap for the supplier price from 13 suppliers and a buyers median price of $0.0184/tab-cap for eight buyers. The pack size for the sellers were all 1000 tablet packs while the buyer pack sizes varied from 1 to 100. Compare these prices with the quoted US original price of $20 per 500 tablets which amounts to $0.04 which is 2.77 times the international sellers price. This difference may be reasonable considering the high cost of generic registration in the US now and other costs.

Why the cost has gone up so rapidly is hard to understand as this is a competitive market as there are 12 different companies listed on the FSS Schedule with widely differing prices. Data available from Pharmacy Benefits management Services managed by US Department of Veteran Affairs at http://www.pbm.va.gov/PharmaceuticalPrices.asp .

It will be interesting to see what comes out of these enquiries.

Richard Laing
Professor International Health
Boston University School of Public Health,
801 Massachusetts Avenue Boston MA 02118
Tel 617 414 1445 (Office) 617 435 7860 (Mobile)
E mail richardl@bu.edu