FDA Complains That Drugmakers Abuse Petition Process To Try To Hold Up Drug Approvals

Regulators tell Congress that many citizen petitions submitted do not raise valid health concerns and waste time because the Food and Drug Administration must review each one. FDA officials say pharmaceutical companies use them as a ruse “aimed at blocking generic or biosimilar competition.”

Stat: Drug Firms Still Abuse Citizen Petitions, FDA Tells Congress

Once again, the US Food and Drug Administration filed an annual report to Congress about citizen’s petitions that can be used to ask the agency to refrain from approving a generic drug or a biosimilar. And once again, FDA officials reiterated complaints that many petitions generally do not raise valid scientific concerns and appear to have been filed to delay approval of competing medicines. This is actually a long-standing issue for agency officials, despite having released new guidelines five years ago that were intended to limit such petitions. (Silverman, 8/22)

And drug companies Advaxis, Pfizer and Medivation are in the news —

Stat: Small Biotech Advaxis, On The Brink Of Ruin, Resurrects Itself

Three years ago, a small New Jersey biotech called Advaxis was on the brink of ruin. Its cancer drug AXAL was in the middle of clinical trials, but the company was out of money and trading as a penny stock.Today, Advaxis is on the upswing. In the past few weeks, the company has earned two big wins — its cancer drug has been fast-tracked for approval to treat cervical cancer by US Food and Drug Administration and the company has inked a valuable partnership with Amgen for another tumor-killing technology. The rapid resurrection of Advaxis is the work of both man and microbe — chief executive officer Daniel O’Connor, who was hired at the company’s rock bottom, and a bacterial species called listeria that’s best known for causing food poisoning. (Weintraub, 8/22)

The Associated Press: Pfizer Spends $14B On Medivation In Cancer Fight

Pfizer will pay about $14 billion to buy cancer drug developer Medivation in a cash deal aimed at fortifying its hold in one of the hottest and most lucrative areas of medicine. The New York drugmaker said Monday that the acquisition will stock its product portfolio with leading treatments for the most common cancers in men and women by adding Medivation's pricey prostate cancer treatment Xtandi to a lineup that already includes the breast cancer drug Ibrance. (8/22)

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