ProPublica has an informative website that shows the relationship between doctors and pharmaceutical companies.

“Drug companies have long kept secret details of the payments they make to doctors and other health professionals for promoting their drugs. But 12 companies have begun publicizing the information, some because of legal settlements. ProPublica pulled their disclosures into a database so patients can search for their doctor. Accepting payments isn’t necessarily wrong, but it can raise ethical issues.”

 

The Washington Post continues its great reporting into Medicare fraud investigations and the pharmaceutical industry.  The inspector general of the Health and Human Services department found that corner drugstores are vulnerable to billion-dollar fraud because Medicare does not require private insurers that deliver prescription benefits to seniors to report suspicious billing patterns.  Using statistical analysis to scrutinize every claim submitted by the nation’s 59,000 retail pharmacies during 2009 — nearly 1 billion prescriptions, investigators were able to reveal contrasts between normal business practices and potential criminal behavior.

The article mentions several examples of questionable billing practices including a pharmacy in Kansas that billed Medicare for more than 1,000 prescriptions each for two patients in a single year.  In Los Angeles, 12 percent of pharmacies had questionable billings, one drugstore in a suburban strip mall billed Medicare more than $8.4 million, nine times the national average. That worked out to an average of 116 prescriptions per beneficiary.  New York had 9 percent of pharmacies filing high numbers of questionable claims.  20 percent of pharmacies in Miami show telltale patterns of questionable billings.

These are just a small part of a pattern of questionable billings at 2,600 drugstores nationwide uncovered by federal investigators. Eight major indicators of potential fraud exist such as billing hundreds of prescriptions for a single Medicare beneficiary; a drugstore whose claims reflect an extremely high share of brand-name drugs may be dispensing generic medications and billing them at the higher rate for expensive brands; a drugstore whose billings show an unusually high share of refilled prescriptions might be billing for refills that patients didn’t ask for and won’t pick up then the pharmacy restocks it for future sale.

 

Lauren Stevens of Durham, N.C., an attorney for a major pharmaceutical company was charged with obstruction and making false statements  She was charged with one count of obstructing an official proceeding, one count of concealing and falsifying documents to influence a federal agency, and four counts of making false statements to the Food and Drug Administration (FDA).

The indictment states that in October 2002, the FDA asked for information about the company’s promotion of a prescription drug, as part of an inquiry into whether the drug was being promoted for uses that had not been approved by the FDA. Data demonstrating a drug’s safety and efficacy for a particular use is required for FDA approval. Federal law prohibits the marketing or promotion of drugs for unapproved – or "off-label" – uses.

The indictment alleges that, in response to the FDA’s inquiry, Stevens signed and sent a series of letters from the company to the FDA that falsely denied that the company had promoted the drug for off-label uses, even though she knew, among other things, that the company had sponsored numerous programs where the drug was promoted for unapproved uses. The indictment alleges that Stevens knew that the company had paid numerous physicians to give promotional talks to other physicians that included information about unapproved uses of the drug. According to the indictment, the company paid one such physician to speak at 511 promotional events in 2001-2002 and another physician to speak at 488 such events during that time period.
The indictment also alleges that Stevens did not provide the FDA with slide sets used by the physicians who were paid by the company to promote the drug, even though the FDA had asked for the slide sets and Stevens had previously promised to obtain and provide the FDA with such materials. The indictment alleges that a memorandum was prepared for Stevens that set forth the "pros" and "cons" of producing the slide sets to the FDA. One of the "cons" was that the slide sets would provide "incriminating evidence about potential off-label promotion of [the drug] that may be used against [the company] in this or in a future investigation." Instead of providing the requested slide sets to the government, Stevens represented that the company’s responses to the FDA’s requests was "final" and "complete."

" This indictment demonstrates that those who purposely subvert the regulatory functions of the FDA through false statements and misleading information will be held accountable for their deception," stated Dara Corrigan, FDA’s Associate Commissioner for Regulatory Affairs.

Each of the obstruction charges carries a maximum penalty of 20 years in prison. Each of the false statement counts carry a maximum penalty of five years in prison.