US probes contracts between drugmakers, pharmacy benefit managers

By REUTERS

Published: 22:15 GMT, 10 May 2016 | Updated: 22:15 GMT, 10 May 2016

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May 10 (Reuters) – The U.S. Attorney’s Office for 레비트라 인터넷 구매 the Southern District of New York is investigating contracts between drugmakers and companies that manage prescription benefits, according to regulatory filings.

Federal prosecutors have approached at least three companies, including Johnson & Johnson, Merck & Co and Endo International Plc, 레비트라 비아그라 차이 demanding information about their contracts with pharmacy benefit managers.

Pharmacy benefit managers, or PBMs, which administer drug benefits for employers and health plans and also run large mail-order pharmacies, have been challenging the rising cost of new medications.

When drugs are knocked off their formularies, patients may have to pay full price for them. PBMs often keep or dump a product depending on whether they can obtain favorable pricing.

J&J said in a regulatory filing on Tuesday it had received a “civil investigative demand”, seeking information about its contractual relationships with pharmacy benefit managers over some of its products from early 2006 through the present. website

Merck said on Monday it had received a demand for information about contracts with, services from and payments made to PBMs in relation to its migraine drug, Maxalt, and erectile dysfunction treatment Levitra, over the same period. website

Endo said last week it was cooperating with such an investigation, looking into its PBM contracts for its migraine therapy, Frova. website

The companies did not disclosed the name of any PBM in their respective filings. Express Scripts Holding Co is the nation’s largest pharmacy benefit manager, followed by CVS Health.

J&J, Merck and Endo and CVS were not immediately available for comment. Express Scripts and the U.S. attorney’s office for the Southern District of New York declined to comment.

Last November, a U.S. unit of Swiss drugmaker Novartis AG agreed to pay $390 million to settle U.S. charges that it paid specialty pharmacies illegal kickbacks in exchange for inducing patients to refill certain medications.

The sector has come under intense scrutiny, particularly after Canadian drugmaker Valeant Pharmaceuticals International Inc was forced to sever ties with Philidor 레비트라 구매 Rx over the specialty pharmacy’s billing practices. (Reporting by Natalie Grover and additional reporting by Parikshit Mishra in Bengaluru; Editing by Saumyadeb Chakrabarty)

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Because we’ve moved from general statements that there were traces of a chemical to a precise measurement there were 39 parts-per-million, many now believe even minute traces can be dangerous. We’ve lost the sense of scale. When we can detect the presence of particles at a subatomic level, we want to believe science has more answers. It’s going where no one has been able to go before, therefore it must know more than those who tried to go before. Except, science doesn’t work like that. The best it can do is say people have been able to replicate the same results from experiments, so this suggests a theory is correct. But the theory is only correct until a better theory comes along with experimental evidence to back it up.

When the erectile dysfunction drugs were going through their clinical trials, there were some effects noted on eyesight. This fell into two classes. First, some men experienced a slight color shift so many objects appeared tinged with blue. Second, some men experienced photosensitivity, i.e. their eyes were painful in bright light. This affected between 3 and 10% of all men going through the trials, and the effects were duly noted on the labels and accompanying patient information. Suddenly, there were stories about men going blind. As a knee-jerk reaction, the FDA required the manufacturers to change the labels to include a warning.

In a sense, this is the precautionary principle at work. As a responsible regulator, the FDA prefers not to take any chances. Except, just how many verified cases of vision loss were there to encourage the FDA into action? The answer comes in a new piece of research. A team went through all the published reports in the peer-reviewed literature. All the results were analyzed using the international probability scales. The result? Between January 2006 and February 2011, there were eight reported cases. Eight cases over five years! And 레비트라 비아그라 차이 even in these cases, there’s no certainty the loss of vision was due to the use of an erectile dysfunction drug. There were other equally valid explanations.

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