by Daniel R. Hoffman, Ph.D.
Some cheerful news related to the pharmaceutical industry emerged on at least a couple of fronts last week. The first item involves the fact that the European Medicines Agency (EMA), the EU's counterpart to America's Food and Drug Administration, said it would begin requiring full disclosure of all data submitted by pharmaceutical companies to gain drug approvals.
Currently the drug companies only disclose their own analyses of the data from clinical trials, not the raw data itself. In the future, however, medical researchers will gain access to this raw data, thereby enabling them to perform the statistical analyses themselves and reach their own interpretations about the comparative benefit of various compounds. While the FDA here is not bound by the EU decision, the action puts pressure on it to follow suit. In any case, as companies submit most of the same studies to gain registration in the U.S. and Europe, the EMA decision will increase transparency in both places.
Not only will researchers be able to assess drugs independently of sponsoring companies, but the bounty of raw data will permit them to develop computer algorithms that potentially link individual patients to the most cost-effective therapies for their conditions.
The federal government's Department of Health and Human Services provided another bit of good news last week when it announced that as of the beginning of July, 89 new practice organizations agreed to act as Accountable Care Organizations (ACOs). ACOs share in the risk of providing cost-effective health care by meeting standards of quality care. In return they gain the opportunity for compensation by sharing in Medicare savings.
Opponents of the Affordable Care Act have argued that the legislation "creates uncertainty" that costs jobs and stalls health care improvements. But bolstered by the Supreme Court's decision to uphold the Act, 154 provider organizations have signed onto Accountable Care status as of July 1, serving more than 2.4 million people across the country. Originally the government's Centers for Medicare & Medicaid had predicted that possibly no more than 50 practice organizations would be willing to accept Accountable Care status.
Finally, the Third U.S. Circuit Court of Appeals, here in Philadelphia, decided that “pay-to-delay” settlements, in which large, branded companies pay off generic manufacturers to postpone the launch of low-cost generics, are presumptively "an unreasonable restraint of trade."
That means if someone sues the branded company to let the generic launch proceed, the defendant maintains the burden of showing its payment to the generic manufacturer wasn't intended to delay low-cost generics from entering the market.
Postponing the launch of generic drugs increases costs for consumers, their insurers and employers, as well as public payers. The FTC determined that pay-to-delay deals cost consumers an extra $3.5 billion each year. So the Third Circuit's Court of Appeals handed down a decision that will likely help people obtain drugs more easily and at less cost.
We can all use a little good news, now and then.
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